1. REGULATIONS OF THE NATIONAL SYSTEM FOR THE CONTROL OF
HUMAN PHARMACEUTICAL PRODUCTS
PRELIMINARY CHAPTER
SCOPE AND COMPETENT AUTHORITIES
ARTICLE 1 - These regulations include technical and administrative standards and other terms or
conditions to be met for registering, importing, exporting, manufacturing, storing, possessing, and
distributing (either free or for good and valuable consideration) pharmaceutical products, for
advertising and/or supplying information about them, and for their use for scientific research.
ARTICLE 2 - The Ministry of Health, through the Department of Public Health, shall be required to
play a guiding and regulatory role in the field of pharmaceutical products, implementing a national
drug policy and issuing technical and administrative standards to be met by public and private
entities engaging in the activities outlined in the previous article and which shall be approved by
relevant administrative acts.
ARTICLE 3 - The Institute of Public Health is the national health authority responsible for the
sanitary surveillance of pharmaceutical products and for ensuring compliance with the provisions
set forth herein, the Sanitary Code and its supplementary regulations, and other laws on the
subject.
The Institute is furthermore responsible for verifying the quality of pharmaceutical products in any
of the stages referred to in article 1; authorizing the installation and operation of pharmaceutical
laboratories; licensing and registering pharmaceuticals and other products subject to these forms
of control; supervising conditions for import, admission, export, manufacturing, and distribution of
this products, and likewise any advertising and information about the same; controlling drugs and
pharmaceutical products that cause addiction, and other psychotropic substances likely to have a
similar effect, in relation to the import, export, and lawful use thereof in the preparation of
pharmaceutical products; and monitoring compliance with the provisions hereunder and other
regulations governing such matters.
ARTICLE 4 - The Regional Health Departments shall be responsible for authorizing the admission of
pharmaceutical products according to the provisions set forth in article 2 of law no. 18,164. In
addition, Regional Health Departments shall be required to enforce and monitor the compliance
with the provisions herein regarding the distribution, storage, and possession of pharmaceutical
products, insofar as these activities are carried out by authorized pharmaceutical facilities, except
for pharmaceutical laboratories.
ARTICLE 5 - For the purposes hereof, the definitions below shall be construed and interpreted as
follows:
1

2. 1) Biological activity: Measurable response of in vivo or in vitro activity or potency
characterizing a certain amount of a pharmaceutical product with respect to a
reference standard.
2) Administration: The act whereby a drug comes into contact with humans, so that a
local or systemic action may be exerted upon absorption thereof.
3) Quality assurance: A comprehensive system designed to ensure that the processes
and their results meet certain quality requirements previously set out.
4) Bioavailability: The amount of an active ingredient from a pharmaceutical form that
reaches the systemic circulation and the speed at which this occurs.
5) Good Laboratory Practice (GLP): A set of rules, operating procedures and practices to
ensure that the data generated by a quality control system is reproducible and
representative, and to guarantee the validity and reliability of such results. Said
technical standards shall be required to be approved by order of the Ministry at the
proposal of the Institute.
6) Good Manufacturing Practice (GMP): Minimum technical standards established for all
procedures with a view to ensure a constant and satisfactory quality in pharmaceutical
products within statutory limits currently in force. Said standards shall be required to
be approved by order of the Ministry at the proposal of the Institute.
7) Drug quantity: Appropriateness of the drug for the use for which it is intended as
determined by its efficacy, safety, and stability, according to its identity, strength,
purity, and others features in accordance with the relevant sanitary registration.
8) Sanitary registration certificate: A document issued by the health authority of the
country of origin or manufacture upon request of the interested party, stating that:
 The manufacturing facilities meet the conditions required by sanitary
legislation in the relevant country for the manufacture and packaging of the
registered product.
 The product is registered in the country issuing the certificate in accordance
with current regulations, indicating the authorized formula in full detail.
 The sale or distribution of the product under any conditions is subject to a
restrictive regime or other special sanitary supervision, if applicable.
9) Quality control: Activities aimed at ensuring the uniformity of product batches at all
manufacturing stages in accordance with identity, strength, purity, and other quality
requirements set out in the respective monograph and authorized in the
corresponding sanitary registration.
10) Shelf control: Product quality checking during retail and distribution to the public
conducted by the Institute or an appointed health authority in accordance with
programmes developed by the Ministry at the proposal of the Institute.
11) Code: Distinctive alphanumeric or numeric combination which makes it possible to
identify a pharmaceutical product unambiguously during its manufacture, storage,
distribution and retail for the purposes of ensuring the traceability thereof.
12) Counter-sample: A limited sample of analyzed products that is kept under the same
conditions as reference samples.
2

3. 13) Quarantine: A transitional period of physical or other type of isolation of raw
materials, materials in any shape or form, and intermediate, semi-manufactured, bulk,
semi-finished or finished products during which their use or distribution is forbidden
while a decision is reached on their release, rejection or reprocessing, in the light of
the results of the respective quality control.
14) Dispensation: The act whereby the professional pharmaceutical chemist supplies a
drug to a person, usually following the prescription of an authorized practitioner, and
provides guidance on its use, influence of food, drug interactions, potential adverse
reactions, storage conditions and other relevant information, as authorized in the
corresponding registration.
15) Distribution: Delivery of the pharmaceutical product to manufacturing facilities,
importers, distributors or other authorized agents.
16) Dosage: The administration interval and period of treatment provided for the dose of
a drug or a pharmaceutical product.
17) Dose: The total amount of a drug or pharmaceutical product in the approved dosage
form administered each time.
18) Plant drug or material: Plant or raw parts thereof used for medicinal or
pharmaceutical purposes.
19) Effectiveness: The capacity of a drug or pharmaceutical product to produce the
desired therapeutic effect as determined by scientific methods and clinical trials in
humans.
20) Insert: Sleeve made of cardboard or other material that protects the blister or strip
and contains the patient information leaflet and/or the authorized graphic label.
21) Dissolution assay: In vitro test performed under predefined experimental conditions
for determining the dissolution rate of a solid active ingredient from a pharmaceutical
form.
22) Dispenser: A package intended for retail of pharmaceutical products authorized for
sale in blisters, strips, envelopes, protective inserts, or other primary packaging
protective systems under the conditions established in the registration.
23) Primary packaging: A material used to hold and envelop pharmaceutical products in
their final pharmaceutical form.
24) Secondary packaging: A tamper-resistant container that holds and protects the
primary packaging.
25) Clinical packaging: A package intended for use only in pharmacies or with medical kits
at healthcare facilities that is supplied or delivered to patients according to the
prescribed dosage and form.
26) Pharmaceutical equivalents: Pharmaceutical products containing identical amounts of
the same active ingredients or salts or esters thereof and having the same
pharmaceutical form and route of administration, but not necessarily the same
excipients, and meet the same or similar quality specifications .
27) Therapeutic equivalents: Pharmaceutical equivalents meeting the same or similar
quality specifications and producing essentially the same effects upon administration
3

4. under conditions described in their labels insofar as potency and effectiveness are
concerned as determined by appropriate tests.
28) Pharmaceutical drug: Registered pharmaceutical product having a distinctive
packaging adapted for its use and designated under a generic name or other
designation. It shall be construed as including elements or devices for its
administration where appropriate.
29) Specifications: Technical document defining the characteristics of a raw material,
material, product, or service and determining which variables should be assessed in
them, further describing the tests, assays and analyses used to determine them and
establishing the criteria for acceptance or rejection.
30) Stability: The capacity of an active ingredient or a finished pharmaceutical product to
keep its original properties according to the specifications set forth and authorized in
their monograph, which guarantees its physical, chemical, biological and
microbiological properties, as appropriate, within specified limits throughout the
effectiveness period.
31) Manufacturing status: The status of a pharmaceutical product within the
manufacturing process (semi-manufactured, bulk, semi-finished or finished).
32) Therapeutic equivalence study: A comparative clinical, bioavailability,
pharmacodynamic or “in vitro” test performed on a reference pharmaceutical product
and another one under evaluation.
33) Real-time stability study: A stability test carried out for the time of the effectiveness
period and under storage, temperature, and humidity conditions determined by the
nature of the product.
34) Accelerated stability study: A stability test designed to increase the speed of chemical
degradation or the physical changes of an active ingredient or a pharmaceutical
product in its primary packaging under severe storage, temperature, and humidity
conditions as part of a formal storage programme for a certain period of time
according to the active ingredient under evaluation, resulting in the determination of
stability for a certain period.
35) Stability study: A series of tests, assays and analyses relating to the physical, chemical,
biological, and microbiological characteristics of an active ingredient or a
pharmaceutical product conducted for the purposes of gathering information about its
stability in order to determine the effectiveness period under certain packaging and
storage conditions.
36) Bioavailability studies: Pharmacokinetic tests following a predefined experimental
design which make it possible to determine the bioavailability of an active ingredient.
37) Pharmacokinetic studies: In vivo assays following a predefined experimental design to
help establish the kinetics of the absorption, distribution, excretion, and metabolic
processes of the active ingredients and metabolites of a pharmaceutical product.
38) Evaluation of a pharmaceutical product: Systematic study of information provided by
the interested party requesting a sanitary registration with respect to the relevance of
administrative and technical records such as pharmaceutical, pharmacological,
4

5. toxicological, clinical, and therapeutic properties in order to determine or certify
whether the product is suitable for the prescribed use.
39) Excipient: Any material used in the manufacture of the products described herein
other than an active ingredient.
40) Retailing: Retail sale of a pharmaceutical product to users or consumers.
41) Pharmacovigilance: A set of activities concerned with the detection, evaluation,
understanding, and prevention of adverse effects associated with the use of drugs.
42) Expiry date: The date as indicated by the month and year, and in some cases the day,
according to the relevant sanitary registration, beyond which the product cannot be
expected to remain stable.
43) Pharmaceutical form: Physical form of a drug to facilitate its fractionation,
dispensation, dosage and administration, or use.
44) Master pattern or formula: A document or set of documents indicating raw materials,
amounts, packaging materials, and a description of the procedures and precautions
for producing a specific amount of a finished product, further indicating
manufacturing instructions and process controls.
45) Import: The act whereby a foreign pharmaceutical product enters the country and is
admitted for distribution in compliance with current regulations.
46) Impurity: Any component not defined as constituting the raw material or product.
47) Admission: The act whereby a foreign pharmaceutical product is placed in a duly
authorized storage site pending approval for distribution and use.
48) License: Power of attorney or authorization lawfully granted by an individual or legal
entity to request, amend or cancel a sanitary registration.
49) Plant markers: Chemically defined constituents of the plant active ingredients of
relevance for quality control purposes, regardless of whether they have therapeutic
activity and can be used to calculate the amount of the plant active ingredients in the
final product, provided they have been quantified in the plant preparation or drug
used as raw material in the preparation.
50) Tolerance margins: Officially authorized percentages and maximum and minimum
amount of an active ingredient in a product.
51) Raw material: Any substance of a particular quality directly involved in the
manufacture of the pharmaceutical form, whether it remains unchanged or is
modified or removed during the manufacturing process.
52) Packaging material: Material used for a primary packaging, a secondary packaging, or
an insert.
53) Monograph: A document containing the technical, pharmaceutical, and scientific
description of the characteristics and properties of a product.
54) Medical sample: A unit of a pharmaceutical drug for free distribution only to legally-
qualified prescribing professionals having the same labelling of the registered product
and indicating its status as a medical sample, which may include further information
for healthcare professionals.
5

6. 55) Reference samples: Samples taken from each batch of finished product that are
required to be kept for one year after the expiry date of the product in their final
packaging and stored under conditions specified in the sanitary registration.
56) Legal sample or counter-sample: A sample taken by the relevant health authority in
its supervisory capacity, registered in a certificate and under chain-of-custody
conditions.
57) Generic name for a pharmaceutical product: A name accepted by the World Health
Organization (WHO) under the International Non-proprietary Names (INN) system or
otherwise in the pharmacopoeias officially recognized in the country.
58) Country of origin: The country from which a pharmaceutical product has been shipped
for importation into Chile, regardless of any territories through which it travels.
59) Manufacturing country: The country where the manufacturing facilities of a
pharmaceutical product are located, with respect to any of the steps required to
obtain a finished product.
60) Effectiveness period: A period as authorized by the Institute in the relevant sanitary
registration during which a product is required to remain stable under the packaging
and storage conditions set out in the corresponding stability study.
61) Potency: Therapeutic activity of a pharmaceutical product for producing a particular
effect endorsed by appropriate laboratory tests or controlled clinical data obtained by
administering the product under the recommended and authorized conditions of use
as prescribed in accordance with the concentration of active ingredients in the
product formula expressed in weight/weight, weight/volume, unit dose/volume, or
any other units referring to an internationally recognized standard.
62) Plant preparation: A pulverized plant or parts thereof, extracts, dyes, squeezed juice,
fatty or essential oils, gums or other product from a particular process, excluding
chemically defined isolated constituents or mixtures thereof, subject to the possibility
that they may contain other components such as solvents, diluents or preservatives
which shall be required to be declared.
63) Active ingredient: A substance or mixture of substances causing a particular
pharmacological effect or having the capacity to cause such an effect upon
administration.
64) Standard operating procedure (SOP): A written document providing updated
instructions numbered in a logical and continuous sequence to perform general
operations not necessarily confined to a particular product or material, which should
be developed, reviewed and updated by competent authorized staff in order to be
followed by technical professionals in charge of the facilities where they are
implemented with a view to draw up additional documentation on manufacturing
processes and for the purposes of quality assurance and control.
65) Bulk product: A product in its final pharmaceutical form.
66) Associated pharmaceutical product: A product comprising two or more active
ingredients in a single pharmaceutical form.
6

7. 67) Combined pharmaceutical product: A product made of two or more pharmaceutical
products included in a single package to be administered sequentially or
simultaneously.
68) Reference pharmaceutical product: A product defined as such by health authorities in
respect of which another requiring a therapeutic equivalence evaluation is compared.
69) Semi-manufactured product: A substance or mixture of partially processed
substances preceding the pharmaceutical form and requiring further manufacturing
steps.
70) Semi-finished product: A product in its final pharmaceutical form and primary
packaging.
71) Finished product: A product in its final packaging, labelled and ready for distribution.
72) Production, production process or manufacture: A set of operations for obtaining a
pharmaceutical product, from the purchase and receipt of materials to the release,
storage and quality control thereof.
73) Adverse drug reaction (ADR): A noxious and unintended reaction occurring at doses
normally used in humans.
74) Serious adverse reaction: An adverse reaction that is fatal or likely to endanger life, or
involving serious disability or incapacity, or that has resulted in hospitalization or its
extension.
75) Unexpected adverse reaction: An adverse reaction undisclosed in the product
monograph or the patient information leaflets, or unknown to the authorized
prescribing professional.
76) Prescription: An order signed by a legally qualified professional so that an amount of
one or more drugs is supplied and administered as indicated.
77) Sanitary registration: The process of evaluation of a pharmaceutical product resulting
in a registration under sequential numbering on a special list held by the Institute prior
to its distribution and use.
78) Graphic label: A graphic representation displaying the officially authorized text in
accordance with the relevant sanitary registration for different types of approved
packaging as appropriate.
79) Batch: A certain amount of raw material, packaging material or processed product
resulting from a single production cycle or continuous steps characterized by its
homogeneity.
80) Sub-batch: A specific and identified fraction of a batch.
81) Possession: The ownership of a pharmaceutical product by an individual or a legal
entity either having the corresponding deed or not.
82) Holder of a sanitary registration: A national or foreign individual or legal entity
domiciled in Chile whose name appears on a sanitary registration.
83) Traceability of analytical data: Features or characteristics of the result of a
measurement or the value of a standard related to specific references, usually
national or international standards, across an unbroken chain of comparisons with
specified uncertainties.
7

8. 84) Traceability of a product: The ability to trace a specific unit of a product along any
stage of the manufacturing process and/or a batch along the distribution chain and
across different relevant entities until it is supplied, administrated or used.
85) Unit of sale: An authorized retail presentation for supply and sale.
86) Validation: A documented action performed in accordance with the principles of Good
Manufacturing and Laboratory Practice with a view to demonstrate that the
procedures, processes, activities or systems used during the manufacture and quality
control of a product are conducive to the results indicated within the established
limits.
ARTICLE 6 - The manufacture, importation, possession, distribution and transfer of pharmaceutical
products for any purpose is prohibited under the following circumstances:
1. Contaminated pharmaceutical product: A product containing microorganisms,
parasites or parts thereof capable of causing diseases in humans, or unauthorized
amounts of potentially toxic, carcinogenic or mutagenic substances or other foreign
materials.
2. Altered pharmaceutical product: A finished product which due to inadequate storage,
transportation, preservation or any other reason after being manufactured:
a. has decreased its activity below the limits indicated in the sanitary
registration, or in the case of raw materials, in quality specifications according
to official texts;
b. has lost effectiveness or undergone changes affecting its quality;
c. is in a damaged packaging, or
d. is distributed or sold after the effectiveness period.
3. Adulterated pharmaceutical product: A product whose composition, specifications or
other conditions indicated in the corresponding sanitary registration, or in the case of
raw materials, in quality specifications according to official texts, have been modified
without permission or compliance with said specifications.
4. Counterfeit pharmaceutical product: An unregistered or unlicensed pharmaceutical
product manufactured or imported without prior sanitary authorization. Additionally,
the foregoing definition shall be construed as including counterfeit products
distributed or sold without authorization.
The Institute shall be required to monitor the existence of such pharmaceutical products and
adopt any sanitary measures or impose the corresponding penalties upon conducting a prior
preliminary investigation.
The Regional Health Departments shall be required to monitor the retail and supply of products
under the conditions described above.
The Regional Health Departments shall additionally be required to inform the Institute of any
findings concerning the conditions described in the preceding paragraph so that the Institute can
adopt the necessary measures or conduct investigations with respect to holders of sanitary
registrations, manufacturers, importers or distributors as appropriate.
8

9. Furthermore, the Institute or the Regional Health Departments shall be required to lodge the
corresponding complaint with the Public Prosecutor's Office with a view to conduct an
investigation and impose criminal liabilities if applicable.
CHAPTER I
PHARMACEUTICAL PRODUCTS
SECTION 1
DEFINITION
ARTICLE 7 - A pharmaceutical product or drug is any natural or synthetic substance, or mixtures
thereof, intended for use in humans in the cure, mitigation, treatment, prevention or diagnosis of
diseases or their symptoms, or for producing changes in the physiological system or mental state
of the individual to whom it is administered.
Pharmaceutical products shall be construed as including active raw materials, pharmaceutical
preparations, pharmaceutical drugs and traditional herbal medicines.
ARTICLE 8 - Based on substantiated decisions, the Institute shall impose an appropriate regulatory
regime on all products having or described as having some of the properties listed in the previous
article and labelled or advertised as food items. The decisions made by the Institute shall be
binding both on products currently in the market as well as those distributed and sold for the first
time.
The determination of the applicable regulatory regime may be made either ex officio or at the
request of individuals or other public organizations upon detecting products under the conditions
mentioned in the preceding paragraph in their capacity as supervisory bodies.
For the purposes of determining the applicable regulatory regime as requested, the Regional
Health Departments shall be required to submit a technical report and copies of all records in their
possession, as well as results from inspections and audits if applicable.
Should the Institute establish that the applicable regulatory regime corresponds to a
pharmaceutical product, the corresponding formal resolution shall be required to be published in
the Official Gazette and a notice shall be served on the interested party for the purposes of
requesting a sanitary registration by providing relevant information for all products comprising
components with the alleged therapeutic activity.
Upon service of the aforementioned notice and prior to obtaining a sanitary registration, the
pharmaceutical product shall be recalled by the distributor or retailer, without prejudice to further
sanitary liabilities. These provisions shall also apply for other products comprising the ingredients
of the pharmaceutical product.
In the event of the Institute finding that the applicable regulatory regime does not correspond to a
pharmaceutical product, the records shall be required to be submitted to the Ministry for review
along with a technical report explaining the reasons behind the decision.
ARTICLE 9 - In addition, the determination of the applicable regulatory regime may be made when
9

10. in doubt about the classification of other products such as cosmetics, household and sanitary
pesticides, or medical devices, following the same procedure outlined above.
SECTION 2
PHARMACEUTICAL DRUGS AND THEIR CLASSIFICATION
ARTICLE 10 - According to their nature, pharmaceutical drugs are classified as:
a) chemical products;
b) biological products;
c) radiopharmaceuticals;
d) phytopharmaceuticals;
e) homeopathic products;
f) medical gases; and
g) other drugs not listed above.
ARTICLE 11 - Chemical products are drugs comprising one or more purified and identified active
ingredients obtained from a chemical synthesis or extraction process.
ARTICLE 12 - Biological products are obtained from and/or produced by living organisms and their
fluids or tissues.
Biological products are classified as follows:
a) Vaccines: Biological products formulated to stimulate active immunity.
b) Serum: Biological product formulated to develop passive immunity.
c) Blood products: Human blood or plasma biological derivatives obtained from
industrial processes using human blood or plasma as raw materials. Specifically, these
drugs include albumin, clotting factors and human immunoglobulin, except for human
whole blood, plasma and blood cells.
d) Hormones: Natural biological products like proteins, amino acid derivatives, spheroids
or lipids used to treat some disorders either by increasing or decreasing their levels.
Synthetic hormones are classified as synthetic products under article 10.a.
e) Biotechnological or recombinant drugs: Genetically engineered protein-like biological
products obtained from the combination of recombinant nucleic acids (DNA and RNA)
and monoclonal antibodies, among others.
f) Antibiotics: Biological products made of substances secreted by a microorganism with
antimicrobial capacity. Synthetic antibiotics are classified as synthetic products under
article 10.a.
g) Allergen: Biological product for identifying or introducing a specific and acquired
modification of the immunological response to an allergenic agent.
h) Gene therapy: Biological product obtained by means of a set of processes for the in
vivo or ex vivo transfer of prophylactic, diagnostic or therapeutic genes (DNA or RNA)
to human and animal cells and their subsequent expression in vivo.
10

11. ARTICLE 13 - Radiopharmaceuticals are products or formulations labelled with radionuclides or
radioisotopes for use in the diagnosis or treatment of diseases, regardless of the route of
administration.
ARTICLE 14 - Phytopharmaceuticals are pharmaceutical drugs comprising standardized active
ingredients from aerial or underground parts of plants or other plant material.
ARTICLE 15 - Homeopathic products are pharmaceutical drugs comprising homeopathic
substances made of plant, animal, mineral or chemical raw materials prepared in accordance with
a homeopathic manufacturing procedure described in official regulations approved by order of the
Ministry necessarily including the processes of dilution and dynamization of mother dyes.
Homeopathic products shall be required to have been tested in healthy individuals and
repertorized for prescription or use according to the law of similars. A homeopathic product may
contain one or more homeopathic substances.
ARTICLE 16 - Medical gases are pharmaceutical drugs made of one or more gaseous components
of known concentration and impurity manufactured according to registered specifications and
intended for administration to humans. Such drugs shall be governed by specific regulations.
ARTICLE 17 - In addition to the aforementioned groups, pharmaceutical drugs include any other
products having therapeutic properties as indicated in the label, advertised or attributed by any
means, whether curative or for the mitigation, treatment, diagnosis or prevention of diseases or
their symptoms, or for changing physiological systems or mental states for the benefit of the
person to whom it is administered, and which are not classifiable under any of the above
categories.
This group includes the following:
a) Products for parenteral administration products, regardless of their properties or
effects.
b) Vitamins, minerals and other nutrients in therapeutic doses as determined in the
respective technical standard approved by order of the Ministry.
c) Animal or mineral products, as well as those comprising plant drugs and preparations
in association with active ingredients of different nature.
CHAPTER II
SANITARY REGISTRATION OF PHARMACEUTICAL DRUGS
AND OTHER PHARMACEUTICAL PRODUCTS
SECTION 1
CONCEPT AND PURPOSES
ARTICLE 18 - The sanitary registration of a pharmaceutical drug is a process of evaluation and
systematic study of its pharmaceutical, pharmacological, toxicological, and clinical properties with
11

12. a view to verify its quality, safety and efficacy, resulting in a registration under sequential
numbering on a special list held by the Institute prior to its distribution and use in the country.
The sanitary registration of a pharmaceutical product does not release the holder from the
obligation to comply with other laws or regulations governing the marketing of such products.
The sanitary registration may be requested by any national or foreign individual or legal entity duly
represented and domiciled in Chile.
ARTICLE 19 - The administrative proceedings concerning the sanitary registration are unrelated to
other commercial or intellectual property aspects as provided for in article 49 of the Industrial
Property Act, in accordance with the consolidated and coordinated text of law-ranking decree No.
3 of 2006 by the Ministry of Economy, Development and Reconstruction.
ARTICLE 20 - No pharmaceutical product, whether imported or manufactured in the country, shall
be distributed or used without prior sanitary registration.
ARTICLE 21 – Under exceptional circumstances, the Institute may authorize the sale or provisional
use of certain pharmaceutical products without the corresponding sanitary registration in view of
the provisions of article 102 of the Sanitary Code including but not limited to the following
circumstances:
a) Epidemics, emergency situations or disasters that may pose a serious risk to the health
or life of the population.
b) In the case of a pharmaceutical product that is required for urgent medical purposes
without there being any other alternative at such time.
c) In the case of products for use in scientific research or clinical trials, following a
favourable report from the relevant ethic committees in accordance with regulations
on clinical trials in humans approved by the Ministry of Health.
ARTICLE 22 - Applications submitted by interested parties for the sale or temporary use of
pharmaceutical products without prior sanitary registration based on a) and b) above shall require
prior authorization granted by the authorities of the country of origin or manufacturing country as
appropriate. In both cases, the authorizations granted to interested parties may be requested for a
second time within six months, upon receipt of the sanitary registration application or proof that
there is still urgent need for the drug, or that the emergency situations mentioned in the
preceding article remain unchanged.
ARTICLE 23 - Applications for provisional use of a pharmaceutical product in scientific research or
clinical trials shall be required to include a protocol approved by the ethics committee as set forth
in article 21.c, which shall also be required in the case of a registered product intended for a
different use other than as authorized.
ARTICLE 24 - Under the collaboration agreements by and between the Institute and the Regional
Health Departments of regions having customs offices pursuant to the provisions of the
12

13. Constitutional Law of State Administration (law no. 18,575) as consolidated and coordinated by
law-ranking decree No. 1 of 2000 by the General Secretariat of the Presidency, the Regional Health
Departments may authorize the temporary use of pharmaceutical products without prior
registration when they have been imported for personal use directly by the applicant or his
representative, provided that they are prescribed by a qualified healthcare professional stating the
need for the treatment and its duration.
Additionally, Regional Health Departments may authorize the admission of drugs by national or
foreign individuals carrying them upon entering the country for treatment for a period not
exceeding three weeks, except in the case of chronic diseases or other therapies, upon providing
the corresponding justification. Any drugs in excess shall be withheld for later confiscation.
Regional Health Departments shall be required to give the Institute a monthly notification of the
authorizations granted pursuant to this article.
ARTICLE 25 - For the purposes of article 102 of the Sanitary Code, pharmaceutical preparations
shall have an official sanitary registration number also appearing in the Official Preparations
Register which shall be deemed the official record of the Institute of Public Health.
ARTICLE 26 - Active starting materials comprising natural or synthetic bulk drugs shall be deemed
to be registered by the fact of being included in the formula of a registered pharmaceutical
product or by the respective authorization for use thereof when such materials are imported by
authorized businesses.
ARTICLE 27 - Traditional herbal medicines are made of plants or whole or crushed parts thereof,
either fresh or dried, hand packed and labelled, designated as is customary in accordance with
local cultural traditions, and recognized in the corresponding technical standard approved by
order of the Ministry as mentioned in the following paragraph. These drugs shall be deemed to be
registered for retail and distribution purposes upon authorization by the relevant Regional Health
Department of the facilities where they are stored, manufactured, packed or fractionated, or
which perform other processing activities, on the following conditions:
a) They shall be required to be listed under a technical standard issued by the Ministry and
approved by a decision adopted in its legal, technical, and administrative capacity,
indicating the name, therapeutic properties and uses thereof as symptomatic aids.
b) They shall be required to be hand-packed as isolated and unmixed plant species.
c) Reference must be made in the label only to those properties established in the
aforementioned decree.
SECTION 2
SANITARY REGISTRATION REQUIREMENTS
ARTICLE 28 - Sanitary registration applications shall be required to be submitted to the Institute in
compliance with the requirements set forth herein.
13

14. General registration requirements include administrative aspects as well as others relating to the
technical information, pharmaceutical quality, safety and clinical efficacy of the pharmaceutical
product; other special requirements depend on the nature of the product, and the healthcare
professional signing the application shall be responsible both for their origin and veracity.
1. Sanitary registration general requirements
A. Administrative requirements
ARTICLE 29 - A sanitary registration application shall be required to meet the following general
administrative requirements and include the following information:
1. Identification and address of the applicant and legal representative in the case of legal
entities.
2. Name of the chief technical officer in charge of the entity requesting the registration
or, if not applicable, of the professional responsible for the technical information
provided.
3. Name of the pharmaceutical product including:
a) trade name, generic or common international name, or otherwise the
pharmacopoeial or chemical name;
b) pharmaceutical form;
c) unit dose per pharmaceutical form; and
d) route of administration.
4. Class or therapeutic group, further indicating the corresponding anatomical-
therapeutic classification.
5. Manufacturing system, including:
a) domestic manufacture, for products manufactured in a legally and technically
qualified pharmaceutical laboratory, whether made at its own premises or by
third parties, or;
b) imported products, including:
i. imported finished products manufactured abroad, whether imported
directly or by authorized third parties;
ii. imported semi-finished products in their final primary packaging to be
fitted in Chile, either directly or by authorized third parties;
iii. imported bulk products in their final pharmaceutical form to be
packed in Chile, either directly or by authorized third parties;
iv. imported semi-manufactured products to engage in other subsequent
manufacturing activities in Chile necessary to obtain a finished
product, either directly or by authorized third parties.
6. Identification of the licensor under the name appearing on the license, if the license is
used for prosecution of the registration.
7. Name and address of the domestic or foreign manufacturing facility.
14

15. 8. Product presentation describing the contents of different packages, retail, clinical
packages and/or medical samples, including elements or devices used for the
administration thereof.
9. Physical description of the packaging material, indicating the type of primary and
secondary packaging materials and other elements or devices used for administration,
if applicable.
10. Legal documents in Spanish or translated versions there of signed by the legal
representative, an appointed professional or the chief technical officer of the
company including the following:
a) For products imported during any stage of the production process:
i. Sanitary registration certificate, pharmaceutical product certificate,
sanitary authorization certificate or official certification recommended
by the World Health Organization, issued by the authorities of the
country of origin and duly legalized, certifying that the manufacturing
facilities meet the requirements established in the sanitary legislation
of their country, that the product is registered in the country
according to current regulations (stating the approved formula in full),
and whether the sale of the product is subject to a restrictive regime
or special sanitary supervision, if applicable.
ii. Legalized manufacturing agreement signed by the applicant and the
foreign manufacturing pharmaceutical laboratory.
iii. Legalized license, if applicable.
iv. Official certificate issued by the competent health authority of the
country where the manufacturing facilities are located certifying that
the foreign manufacturer is duly authorized in their country and
follows Good Manufacturing Practices in accordance with WHO
recommendations, indicating production areas or types of products
authorized for manufacture, unless such information is included in the
document mentioned in a.i herein.
v. Legalized import agreement executed before a notary public, if
applicable.
vi. Manufacturing and/or domestic distribution agreement executed
before a notary public, attaching the corresponding sanitary
authorization for each facility.
vii. Quality control agreement entered into with a pharmaceutical
laboratory authorized by the Institute and executed before a notary
public, if applicable.
b) For domestically manufactured products:
i. Manufacturing and/or domestic distribution agreement executed
before a notary public, attaching the corresponding sanitary
authorization for each facility.
ii. Legalized license if applicable.
15

16. iii. Quality control agreement entered into with a pharmaceutical
laboratory authorized by the Institute and executed before a notary
public, if applicable.
ARTICLE 30 - In the case of imported finished, semi-finished, semi-manufactured or bulk
pharmaceutical products, the applicant shall be allowed to prove the manufacturer's compliance
with Good Manufacturing Practices in accordance with the provisions of articles 192 and 193, in
which case the requirements set forth in a.iv above shall not apply.
B. Technical information requirements
ARTICLE 31- A sanitary registration application shall be required to meet the following general
requirements in relation to the technical information of the pharmaceutical product, including the
following:
1. Clinical and pharmacological monograph in Spanish signed by the chief technical
officer or technical adviser.
2. Graphic labelling draft in Spanish intended for retail, clinical sales and medical
samples.
3. Draft of the healthcare professional information leaflet endorsed by relevant scientific
data and including the results of bioavailability and therapeutic equivalence studies in
the case of pharmaceutical products comprising active ingredients that are subject to
this requirement.
4. Draft of the patient information leaflet endorsed by relevant scientific data.
C. Pharmaceutical quality requirements
ARTICLE 32- A sanitary registration application shall be required to meet the following general
requirements to certify the pharmaceutical quality of the product, including the following
information:
1. Qualitative and quantitative composition of the pharmaceutical product in the
following order:
a) Quali-quantitative statement for each active ingredient.
b) Quali-quantitative statement for each excipient.
c) Qualitative statement of any excipient used and removed during the
manufacturing process, if applicable.
d) Quali-quantitative composition expressed in metric system units of mass or
volume, or units of biological activity. Whenever possible, the biological
activity shall be required to be indicated per unit of mass or volume.
e) Active ingredients and excipients shall be required to be designated by their
international non-proprietary names (INN) or otherwise by the existing
pharmacopoeial names. In the case of non-pharmacopoeial substances, the
16

17. chemical name in Spanish shall be used. No abbreviations or marks may be
used for designating active ingredients.
f) Any colourings in the product shall be required to be designated by their
generic names or otherwise by their chemical name or equivalents having
authorized colouring indexes in accordance with the relevant national
technical standard as approved by order of the Ministry; the same provision
shall apply when using coloured capsules.
2. With respect to the active ingredients used in the manufacture of pharmaceutical
products, the following information shall be required to be supplied:
a) Specifications and quality control methods, conforming to the requirements
listed in official texts or pharmacopoeias currently in force in Chile, or in
pharmacopoeial monographs if not indicated in the official texts.
b) Supplier and manufacturer of the active ingredients, including an analysis
report detailing all the characterizing parameters of the active ingredient.
c) Origin of the primary reference standard, including the corresponding
certificate of analysis indicating at least its origin, potency, traceability and
other relevant characterizing tests.
d) Spectrogram or chromatogram of the active ingredient and the standard
obtained by any instrumental method, if applicable.
e) Storage conditions of the active ingredient used as raw material.
3. Specifications and control methods for every excipient, conforming to the
requirements listed in official texts or pharmacopoeias currently in force in Chile, or in
pharmacopoeial monographs if not indicated in the official texts.
4. Analytical methodology in Spanish signed by the professional filing the application and
by the quality control manager of the pharmaceutical laboratory or the contracted
supplier.
a) The analytical methodology shall characterize the pharmaceutical product and
include controls as necessary to guarantee its quality, depending on the
manufactured pharmaceutical form.
b) The analytical methodology of all pharmaceutical products shall be required to
include the following general test methods: sensory description (appearance,
size, shape, colour, odour, etc.); selective identification of active ingredients;
titration, performance or activity of active ingredients; identification of
impurities if applicable; and description of the type and material of both
primary and secondary ary packaging.
c) Specific test methods according to the pharmaceutical form shall be
established pursuant to current additional technical standards issued by the
Institute.
d) The methodology is required to be validated, if not described in officially
recognized pharmacopoeias.
5. Special tests:
17

18. a) Modified-release pharmaceutical forms, such as delayed-release or enteric
prolonged-release forms and others, shall be required to be indicated as such
and endorsed by pharmacokinetic, dissolution or dissemination tests, or other
studies.
b) Therapeutic equivalence and bioavailability studies, in the case of
pharmaceutical products comprising active ingredients subject to this
requirement.
6. Fact sheet including analytical parameters and acceptance criteria characterizing the
product which, upon being made official, shall become the specifications that the
finished product shall be required to meet throughout its effectiveness period.
7. Proposed effectiveness period and storage and packaging conditions for both the
pharmaceutical drug and the reconstituted product if applicable, endorsed by the
corresponding stability tests, including the following:
a) Stability information, including at least: identification of the manufacturer and
the entity or individual responsible for conducting the stability test;
temperature and humidity conditions, packaging material and batches
(minimum 3 batches); test design and analytical procedures; and
specifications of the finished product; all of the above in accordance with the
Guide to the Stability of Pharmaceutical Products, a technical standard
approved by the Ministry at the proposal of the Institute.
b) When the product requires dilution prior to administration, the stability tests
for the formulation, the solvent (if included in the presentation) and
reconstituted product. In the event of the product requiring dilution and the
solvent not being included in the presentation, there shall be an indication as
to the recommended solvents; stability tests for the formulation and the
reconstituted product shall be additionally required.
c) If the product is required to be diluted for immediate administration, only a
compatibility study for the corresponding diluents shall be required.
d) In the case of an active ingredient that is not part of the authorized formula of
a registered pharmaceutical drug, the results of forced degradation studies
under stress conditions, as well as the requirements established in #2 above.
8. Technical information relating to the manufacturing process and the code for the
product, quality control, and physical-chemical data, presented in a record sheet
including flow charts and controls along the process.
ARTICLE 33 - For the purposes of determining the identity, potency, purity, stability, and other
physical, chemical, microbiological and bio-pharmaceutical requirements for drugs for which a
registration is sought, the Institute shall be required to observe the relevant rules in the following
pharmacopoeias and their supplements:
a) Chilean Pharmacopoeia.
b) International Pharmacopoeia.
c) European Pharmacopoeia.
18

19. d) United States Pharmacopoeia and the National Formulary.
e) British Pharmacopoeia.
f) French Pharmacopoeia.
g) German Pharmacopoeia.
h) German Homeopathic Pharmacopoeia.
i) Wilmar Schwabe Pharmacopoeia.
j) US Homeopathic Pharmacopoeia.
k) Mexican Homeopathic Pharmacopoeia.
l) Japanese Pharmacopoeia.
m) Spanish Pharmacopoeia.
n) Mexican Pharmacopoeia.
In addition, the technical reports of the World Health Organization Expert Committee on
biological, biotechnological, chemical, radioactive, and similar standards, and the provisions of title
21 of the United States “Code of Federal Regulations” (CFR), section 1.1, shall also be of relevance
for the purposes mentioned above. In the case of a pharmaceutical product that is not listed in any
of the foregoing official documents, the Institute may, with good reasons, accept or reject, either
totally or in part, the technical information supplied by the interested party.
ARTICLE 34- Should reference be made to tolerance margins or other specifications in the texts
mentioned in the preceding article, these shall be indicated in the application for registration so
that the Institute can decide about their adequacy.
ARTICLE 35- Due to the nature, diversity and extent of the general requirements set for the
pharmaceutical quality of products, they may be listed in additional technical standards approved
by the Ministry at the proposal of the Institute.
D. Safety and Efficacy requirements
ARTICLE 36- A sanitary registration application shall be required to include information on the
safety and efficacy of the product, including the following:
1. Studies on the development of the pharmaceutical product, including chemical,
pharmaceutical, and biological tests as appropriate for the proposed formulation and
their rationale.
2. Preclinical trials such as those conducted in vitro and/or with experimental animals
usually designed to gather further information as to whether more extensive studies
should be carried out in humans without exposing them to undue risk.
3. Selective pharmacological studies in animals.
4. Toxicological studies in animals, including acute and chronic toxicity, teratogenicity,
embryotoxicity, fertility, mutagenesis, and carcinogenesis tests, as well as any other
assays necessary for a proper evaluation of the safety and tolerance of a
pharmaceutical product pharmacist.
19

20. 5. Phase I, II, and III clinical trials endorsing the safety and efficacy of a product for which
registration is sought. Trials of products that do not correspond to the formula
intended for registration may be submitted, provided that their pharmaceutical and
therapeutic equivalence has been established by the corresponding studies.
6. Pharmacokinetic tests, if applicable.
7. Studies to prove the bioavailability or therapeutic equivalence of a pharmaceutical
product whose registration is sought, in the event of products comprising active
ingredients that are subject to this requirement.
8. A chemical, pharmaceutical, and biological report, including analytical, chemical,
physical, chemical, biological or microbiological tests to determine if the product
intended for registration is in conformity with the stated composition and has the
appropriate quality, and whether the proposed control methods are in accordance
with the state of scientific knowledge, the formulation and pharmaceutical form are
suitable for their intended purposes, and the container is suitable for proper
preservation.
9. A toxicological and pharmacologic report, including preclinical trials reporting the
toxicity of the product and its proven pharmacological properties.
10. A clinical report prepared by independent experts evaluating the tests submitted by
the applicant with regard to the product having an adequate tolerance, the
recommended dosage being correct, and any eventual contraindications or side
effects.
2. Registration details and conditions for certain pharmaceutical drugs
ARTICLE 37 - The following conditions shall be required to be met for the registration of
pharmaceutical products comprising a combination of fixed-dose active ingredients:
a) Each active ingredient is required to contribute to the therapeutic effect of the
product, and the combination should contribute to improving patient compliance with
the treatment.
b) The dose of each component, the frequency of administration, and duration of the
treatment shall be required to render the combination safe and effective while
avoiding the danger of adverse reactions.
c) The ingredients including excipients used in the combination are required to be
chemically, pharmacologically, pharmacokinetically, and biopharmaceutically
compatible, either in vitro or in vivo, as appropriate.
d) Toxic or side effects should be the same or less than those found in each of the active
ingredients separately.
ARTICLE 38- Notwithstanding the foregoing, applications for the registration of pharmaceutical
products comprising a combination of fixed-dose active ingredients shall be rejected under the
following circumstances:
20

21. a) The products have been indicated for treating diseases or symptoms having a different
natural course than the one mentioned in the registration for each of its active
ingredients unless proven otherwise.
b) Clinical, pharmacological or other tests subject to evaluation are not available for any
of the components.
ARTICLE 39 - In the case of combined pharmaceutical products, the applicant requesting their
registration shall be required to provide evidence of their safety and efficacy when used in the
combination. In addition, the applicant shall be required to provide further evidence as to the
following:
a) Each pharmaceutical drug should contribute to the therapeutic effect of the combined
product.
b) The dose for each drug as well as the frequency of administration and duration of the
treatment shall be required to render the combination safe and efficient without any
danger of causing adverse reactions.
c) The ingredients used in each pharmaceutical drug, including excipients, shall be
required to be chemically, pharmacologically, pharmacokinetically, and
biopharmaceutically compatible, both in vitro and in vivo as appropriate.
d) Toxic or side effects should be the same or less than those found in each of the active
ingredients separately.
Combined products may not include phytopharmaceutical or homeopathic products in association
with each other or with other pharmaceutical drugs.
ARTICLE 40 - Given the nature of phytopharmaceutical products, the following considerations shall
be taken into account for their registration:
a) Proof of their safety shall be required by submitting pre-clinical trials and toxicological
and phase I clinical studies, while their effectiveness shall be endorsed by phase II and
III clinical trials. In the event that upon requesting the sanitary registration of a
product there exists information in the official literature of different international or
foreign agencies such as the WHO, FDA or EMEA, such information shall be accepted
as valid in lieu of the above.
b) Applications shall be required to observe the provisions set forth under the general
registration requirements, including the following special rules:
i. Therapeutic equivalence studies shall not be required at the time of
registration or when requesting any subsequent modifications.
ii. The description of the manufacturing process shall be required.
iii. The generic name shall correspond to the taxonomic botanic denomination of
the plant providing the active ingredients.
iv. The quali-quantitative formula shall be required to include the type of plant
preparation used for the product, such as dry or fluid extracts, soft extracts,
powder or others, followed by the plant or parts thereof that have been
21

22. employed in the preparation, plus their scientific name, concentration and its
equivalent plant marker, if applicable.
v. No narcotic or psychotropic substances or allopathic medicines shall be
allowed in the preparation.
vi. The identity and purity of the ingredients shall be determined in accordance
with foreign or international pharmacopoeias or sources of information, and
shall be required for validating the proposed analytical methodology.
vii. The analytical methodology for evaluating the finished product and the raw
materials should appear in any of the pharmacopoeias officially accepted in
Chile or in foreign sources of scientific information, or otherwise the
corresponding validation of the proposed analytical methodology shall be
required.
viii. Finished product specifications shall be required in accordance with the
pharmaceutical form of the product. Notwithstanding the foregoing, the
titration of active ingredients in the finished product may be replaced with the
titration of specific plant marker.
ix. Products comprising isolated or synthetic active ingredients shall not be
deemed to be phytopharmaceuticals, even if prepared from plant raw
materials.
ARTICLE 41 - Given the nature of homeopathic products, the following considerations shall be
taken into account for their registration:
a) Regarding information on the pharmaceutical quality of the product:
i. Generic names of active ingredients shall be required to be in Latin as set
forth in recognized pharmacopoeias.
ii. In qualitative-quantitative formulas, each homeopathic substance shall be
required to be in Latin, followed by the final dilution (i.e. in the finished
product) and concentration.
iii. A clear and complete description of the starting raw materials used in the
preparation of the homeopathic substance shall be required, in addition to
their characterization, method of preparation, and any physicochemical
controls to which they have been submitted.
iv. A description of the manufacturing methods used for preparing the finished
product.
v. Homeopathic pharmaceutical products shall be required to meet finished
product specifications according to the pharmaceutical form in which they are
presented, like any other drugs, except for the titration of the active
ingredients in the finished product.
vi. When homeopathic products are administered as conventional tablets,
disintegration tests shall be required instead of dissolution tests.
b) With respect to information endorsing the efficacy and safety of the product, in
addition to the texts particularly mentioned in article 33 herein, the use of other
22

23. pharmacopoeias, documents issued by WHO expert committees, or other references
acknowledged by decree of the Ministry may be authorized under the formula “By
order of the President of the Republic” at the proposal of the Institute.
ARTICLE 42 -In addition to meeting general product registration requirements, applications for the
sanitary registration of biological products shall be required to include the following information:
a) Name of the product, in the following order:
i. Trade name or otherwise the generic (INN) or pharmacopoeial name. Vaccines
shall be designated with a Latin name after the disease against for which they
provide protection.
ii. The manufacturing process when the active ingredients are living or dead
microorganisms, referring to the process as “living”, “attenuated,”
conjugated”, “inactivated” or others.
iii. The manufacturing method, in the case of active ingredients produced by a
living organism that has been genetically modified, referring to the process as
“recombinant”.
iv. Pharmaceutical form and dosage, if appropriate.
b) Quali-quantitative composition in the following order:
i. Quali-quantitative statement for each active ingredient.
ii. Quali-quantitative statement for each of excipient.
iii. Quali-quantitative statement for any adjuvant or adsorbing agent in the
product, if applicable.
iv. Quali-quantitative composition shall be required to be stated (if applicable) in
units of mass or volume in the metric system. The protein content or units of
biological activity shall be required to be stated in units of mass or volume, or
alternatively in International Units.
v. In the case of products for active immunization, the quali-quantitative
composition shall be preferably stated in unit doses.
vi. Active ingredients and excipients shall be required to be designated by their
international non-proprietary names (INN) or otherwise by existing
pharmacopoeial names. Substances other than drugs shall be required to be
named after their chemical or biological denomination, while vaccines shall
bear a Latin name in accordance with disease against which they offer
protection. No abbreviations or marks may be used for designation.
vii. The taxonomic designation of microorganisms shall be required to be stated in
short, including the strain, serotype or other subspecies information when
appropriate.
viii. The nature of any cellular system used for manufacturing biological products
shall be required to be disclosed, as well as the use of recombinant DNA or
RNA technology.
ix. In the event of an active ingredient being a living microorganism, the chemical
compound used in the chemical inactivation method shall also be disclosed.
23

24. x. Should the quali-quantitative statement include adsorbing agents such as
aluminium, the quantitative statement shall be required to be in terms of
amount per dose.
xi. Preservatives shall be quantitatively detailed at the end of the formula, if
present, which shall also be required to include qualitative details of antibiotic
residues and antimicrobial agents used in the manufacturing process that may
potentially trigger allergic reactions in certain individuals.
xii. Any colourings in the product shall be required to be designated by their
generic names or otherwise by their chemical name or equivalents having
authorized colouring indexes in accordance with the relevant national
technical standard as approved by a decree of the Ministry. The same
provision shall apply to the use of coloured capsules.
c) Active ingredient requirements, including quality and purity specifications and control
methods therefor, along with following information:
i. Manufacturer and supplier of the active ingredient.
ii. Supplier and traceability (if applicable) of the reference standard used for
describing the active ingredient.
iii. Storage conditions of the active ingredient, including temperature, humidity
and quality of the package.
iv. Description of other desired elements and related compounds, including their
properties and characteristics, structure, biological activity or others.
v. When describing active ingredients obtained from human blood or blood
products, the information shall be required to further indicate the procedures
followed to guarantee to the fullest extent the absence of potentially
pathogenic agents that may be transmitted, including:
1. Donor selection protocols.
2. Plasma fractionation method.
3. Testing of the plasma before and during the process, including the
determination of hepatitis B virus (HBV) surface antigens and
antibodies to Human Immunodeficiency Virus (HIV) and Hepatitis C
virus (HCV ), as well as others as appropriate.
4. Storage temperature of the active ingredient and monitoring method.
5. Validity and expiry date.
6. Methods of inactivating infectious contaminants that the starting
material may contain, as well as intermediate and final products.
d) Manufacturing method:
i. Description of the manufacturing method, including process controls and
tolerance.
ii. Description of the manufacturing process, including raw materials, critical
steps and reprocessing if applicable, as well as an indication as to how routine
monitoring methods have been selected for controlling the finished product.
24

25. iii. Description of source and starting materials for the production of the
biological active ingredient.
iv. Description of actions taken to prevent or control contamination by both viral
and non-viral adventitious agents such as HIV, HSV, HCV, transmissible
spongiform encephalopathy (TSE), bacteria, mycoplasma or fungi.
v. Description and information about the validation process.
e) Control of excipients:
i. Quality and purity specifications, as well as methods of controlling excipients
used in the formulation pursuant to the requirements set forth in official
documents authorized hereunder or otherwise in their monographs.
ii. A certification attesting to the absence of raw materials from animal species
affected by TSE and other transmissible diseases.
f) Control of finished products:
i. At least the following information shall be required:
 Description and appearance (shape, colour, odour and clarity if
applicable).
 Selective identification of active ingredients.
 Titration, potency or activity of active ingredients.
 Determination of impurities, if applicable.
 Description of the nature and type of both primary and secondary
packaging material and accessories, in the event of the latter being in
contact with the pharmaceutical product.
 Any other information as required by the Institute according to the
nature and composition of the biological product.
ii. Indication of acceptance criteria and minimum and maximum values if
considered to be deciding factors.
iii. Fact sheet, including laboratory parameters and acceptance criteria
characterizing the biological product which, upon being made official, shall
become the specifications that the finished product shall be required to meet
throughout its effectiveness period.
g) Packaging material:
i. Description of the nature and type of both primary and secondary packaging
material and accessories, in the event of the latter being in contact with the
pharmaceutical product.
ii. Information regarding the choice of primary packaging materials in view of the
protection against light and moisture, and their compatibility with the
pharmaceutical form and its administration.
iii. When the dosage form is sterile, information shall be required on the integrity
of the package sealing system used to prevent microbial contamination.
h) Stability tests for the formulation, the solvent and the reconstituted product, as
appropriate:
25

26. i. The information on the stability of the product shall be required to include at
least the following:
 Formula under study.
 Identification of the manufacturer and the entity or individual
responsible for conducting the stability test.
 Temperature and humidity conditions, packaging material and
batches (minimum 3 batches), test design and analytical procedures,
and specifications of the finished product, all of the above in
accordance with the Guide to the Stability of Pharmaceutical Products
referred to in article 32.
ii. In the event of a biological product containing a new active ingredient in the
field of medicine in Chile, the information shall be required to include the
results of studies on forced degradation stability and stress conditions.
iii. Proposed effectiveness period and storage precautions as endorsed by the
corresponding stability test, in addition to the effectiveness period for the
reconstituted product, if applicable.
iv. In the event of the product requiring dilution prior to administration, the
information shall be required to include compatibility and stability tests with
adequate diluents, as appropriate.
i) Efficacy and safety requirements.
In the case of biotechnological products, a technical standard shall be approved by order of the
Ministry at the proposal of the Institute to determine active ingredients and their presentation, for
which abridged clinical studies endorsing the efficacy and safety of the product shall be accepted
based on the existence of another registered biotechnological product comprising the same active
ingredients, unit dose, pharmaceutical product and route of administration.
Notwithstanding the foregoing, the applicant shall be required to submit comparative studies
including the reference product for each indicated active ingredient in order to properly
characterize the product and provide evidence as to the similarity in their nature.
SECTION THREE
REGISTRATION APPLICATION PROCEDURES
ARTICLE 43 - The sanitary registration application and any required information depending on the
type of pharmaceutical product shall be submitted to the Institute of Public Health using the
approved forms upon payment of the corresponding fee.
A register of the application shall be kept on a written or electronic file comprising documents
submitted by interested parties, stating the time and date of presentation and having a reference
number for reference and tracking purposes, upon payment of the fee corresponding to the first
admissibility phase of the application.
ARTICLE 44 - Within ten working days, the Institute shall be required to review the application
form and the information supplied, and deliver a statement on its admissibility.
26

27. ARTICLE 45 - Upon acceptance of the application for further evaluation, the interested party shall
be given notice of this decision in order to proceed with the payment of fees corresponding to the
next phase of the procedure.
An application may only be rejected in the absence of compliance with the requirements
hereunder and any supplementary regulations, according to the type of pharmaceutical drug, and
the Institute shall be required to indicate any missing information required to overcome the
objection, which shall be submitted within five working days, upon which the Institute shall
proceed as provided in the preceding paragraph or eventually turn down the application.
ARTICLE 46 - Upon admission of the registration procedure, the application shall be forwarded to
the appropriate department for the separate analysis of technical and administrative information.
The administrative records referred to in article 29.10 shall be first checked by the legal
consultancy department.
Technical records concerning requirements in relation to the technical information,
pharmaceutical quality, safety and efficacy of the product, as well as any other particular records
as required by the type of product pursuant to the provisions of the preceding paragraph, shall be
separated and forwarded to specialized technical offices for assessment in accordance with these
presents.
ARTICLE 47 - Should the aforementioned assessment result in a favourable outcome and within six
months from the date of payment of the corresponding fee, the requested registration shall be
granted by enactment of a resolution notified to the formal applicant.
ARTICLE 48 - The sanitary registration of a pharmaceutical drug shall be required to contain at
least the following information:
a) Name and address of the holder.
b) Name and address of the manufacturer, importer, manufacturing or packaging
pharmaceutical laboratory, quality control laboratory, distributor, and licensor, if
applicable.
c) Registration number.
d) Name of the pharmaceutical product.
e) Full qualitative and quantitative composition.
f) Pharmaceutical form.
g) Therapeutic group.
h) Storage conditions and effectiveness period.
i) Packaging and presentations.
j) Authorized therapeutic indications.
k) Prescribing and retail conditions pursuant to Ministry regulations.
l) Whether the product is subject to legal control, batch control or others, indicating the
conditions for the same.
27

28. m) Authorization restrictions concerning the validity of the registered product and the
need to supervise the use thereof.
n) Specific obligations of the holder.
o) The obligation to inform about the first batch of production or import for distribution
in any shape or form pursuant to the provisions of article 71 herein.
p) Other relevant information depending on the nature and specific composition of each
pharmaceutical product and relating to the production, import, quality control,
storage, distribution or delivery of the product, and the protection of undisclosed
data.
q) The authorized graphic label, the patient information leaflet or insert, the healthcare
professional information leaflet, and the specifications and testing methodology of the
finished product must be included in one or several stamped attachments, which shall
be deemed to be an integral part of the registration certificate.
ARTICLE 49 - A sanitary registration may be rejected under the following circumstances:
 Incidental issues: upon notification, the applicant shall have 15 working days to make
any submissions as deemed appropriate, after which the Institute shall be required to
issue a final resolution.
 Inadequate tests or insufficient information: upon notification, the applicant shall
have 30 working days to provide further information, and the sanitary registration
shall be granted if such information is sufficient to fulfil the conditions listed above.
In the event that such additional information is not submitted within the allowed period of time,
or if despite having been submitted in time such information is once again deemed to be
insufficient, the Institute shall request the Ministry of Health to rule on the rejection of the
registration.
The Ministry shall be required to issue a report on the rejection of the registration within 10
working days and forward it to the Institute so that it passes a substantiated resolution which shall
be notified to the applicant.
ARTICLE 50 - Pursuant to the provisions of law no. 19,880, during the prosecution of a sanitary
registration the interested party may make submissions and furnish documents or other evidence
which shall be considered for the grant or rejection of the relevant sanitary registration.
Upon grant of the sanitary registration, the corresponding resolution shall become available on
the official website of the Institute of Public Health.
In the event that such information cannot be disclosed pursuant to the provisions of law no.
19,039, the provisions under said law and other supplementary regulations shall be observed.
SECTION 4
SPECIAL REGISTRATION PROCEDURES
1. Short registration procedure
28

29. Article 51 - The regular registration procedure may be simplified to reduce processing times by
order of the Ministry of Health under any of the following circumstances:
1. The pharmaceutical product is required to be supplied to the public in compliance
with health plans or programmes approved by the Ministry to address health risk
situations or particular conditions specific for certain groups of people in the context
of national public health interests.
2. The pharmaceutical product has been included in a list of products under the National
Formulary, in which case the applicant shall be required to use the formulary
monographs to speed up the prosecution of the registration. The Institute shall be
required to reduce registration processing times depending on the stage of the
prosecution. In any case, the entire prosecution may not exceed four months.
2. Simplified registration procedure
ARTICLE 52 - The regular registration procedure may be simplified upon the interested party's
request by leaving out certain information as indicated below:
1. In the case of pharmaceutical products comprising the same active ingredient, in the
same amounts, pharmaceutical form and route of administration as another
registered product whose registration has not been cancelled by the Institute due to
public health reasons, information on safety and efficacy shall not be required to be
submitted, unless the Institute by means of a substantiated decision determines the
need for some or all of such information. In the case of a non-standard release
pharmaceutical product, the corresponding therapeutic equivalence studies shall be
required to be submitted.
2. In the case of widely recognized active ingredients which have been the subject of
ample experimentation so that their efficacy, safety of use and adverse reactions are
widely reviewed in the scientific literature, information on pre-clinical trials may be
replaced with the relevant bibliography. In addition, scientific information relating to
the efficacy and safety of the product intended for registration may also be partially
omitted, in which case the Institute shall review the application and reasonably
require all the necessary information.
3. In the event of a pharmaceutical product being pharmaceutically equivalent to a
registered product and listed under active ingredients for which evidence of
therapeutic equivalence has been required, the corresponding studies shall be
required to be submitted pursuant to specific regulations.
4. In the event of a product having been manufactured in Chile for the sole purpose of
exportation, deemed to be a pharmaceutical product under Chilean regulations and a
food product in the country of destination as certified by the relevant health
authorities, information on safety and efficacy may be omitted unless the Institute by
means of a substantiated decision determines the need for some or all of such
information.
29

30. ARTICLE 53 - The simplified sanitary registration procedure shall not be applicable in the following
cases:
a) The pharmaceutical product for which registration is sought appears for the first time
in the field of medicine in Chile, except under the provisions of article 52.2.
b) The pharmaceutical product for which registration is sought comprises the same
active ingredient as another registered product, and the disclosure of information
about such product is protected under the provisions of section 2, title VIII of law no.
19,939.
c) The pharmaceutical product for which registration is sought is concerned with a new
therapeutic use, dosage schedule, extension of a previously approved route of
administration, or age group.
d) The drug product for which registration is sought health presents a change in the
composition and concentration of active ingredients over a registered formula, or
contains new salts, esters, complexes or isoforms of the active ingredients in a
registered pharmaceutical product, or comprises combinations of separately
registered or unregistered fixed-dose active ingredients.
e) In the event of the pharmaceutical product for which registration is sought being in a
different pharmaceutical form and wherein the release of active ingredients has been
modified.
f) In the case of a combined pharmaceutical product for which registration is sought for
the first time.
g) When requesting the registration of a biological product.
ARTICLE 54 - The registration procedure of homoeopathic pharmaceutical products may only be
simplified upon meeting all of the following conditions:
a) The route of administration is oral or external.
b) Absence of specific therapeutic indications in the graphic label or in healthcare
professional and patient information leaflets.
c) The product comprises a single homoeopathic substance to a degree of dilution that
guarantees the safety of the drug.
d) The homoeopathic substance making up the pharmaceutical product is obtained from
a plant, animal, mineral or chemical substances and raw materials described in
officially recognized pharmacopoeias in accordance with homoeopathic
manufacturing procedures also described in such texts.
SECTION 5
TERM, SUSPENSION AND CANCELLATION OF THE SANITARY REGISTRATION
ARTICLE 55 - The sanitary registration of a pharmaceutical product shall be valid for a term of five
years from the date of grant and may be renewed for equal and successive periods provided that
no cancellation is in effect and under the following conditions:
30

31. 1. Payment of corresponding fees.
2. The objections for suspending the sanitary registration have been overcome within
the required term. In the event of the sanitary registration expiring before such term,
the renewal shall be requested within 15 days after expiration of the term allowed to
overcome the objections.
3. Absence of outstanding fines or compliance with other sanitary measures or penalties
imposed by the Institute, if applicable, in connection with the registration for which
renewal is sought.
The renewal of the sanitary registration shall be rejected upon the holder failing to fulfil some of
the obligations under such registration.
ARTICLE 56 - The application for renewing a sanitary registration shall be submitted to the
Institute, and in the case of imported products, it shall be required to be accompanied by the
pharmaceutical product certificate, registration certificate, sanitary authorization or official
certifications recommended by the World Health Organization, issued by the relevant authorities
in the country of origin, certifying that the manufacturing or storing facilities comply with health
regulations in their respective country, that the product is registered in said country pursuant to
current legislation, indicating the authorized formula in full, and that the sale of the product is
subject to a restrictive regime or other special sanitary controls, if applicable.
ARTICLE 57 - The renewal of the registration shall be required to bear the same number assigned
upon registration, as well as the year of renewal and the expiry date.
ARTICLE 58 - Sanitary registrations could be suspended for any of the following reasons:
1. If significant changes are noticed in connection with the therapeutic indication,
composition, dosage forms, application or other conditions as indicated on the label or
the healthcare professional information leaflet or advertised, and such changes do not
conform to the approved sanitary registration.
2. If the quality of the product is not up to standard in two batches.
The resolution whereby the sanitary registration is suspended shall be required to indicate the
scope of the suspension and set a deadline for overcoming the objections causing the suspension;
upon failure to overcome said objections, the registration shall be cancelled.
ARTICLE 59 - Sanitary registrations may be cancelled ex officio or upon complaint of any interested
parties by order of the Ministry of Health for any of the following reasons:
a) When on the basis of scientific information from the World Health Organization or
foreign or international bodies or organizations, or arising from its own research, the
Institute has the conviction that a product is not safe or effective as indicated in the
relevant sanitary registration, and one of the following situations develops:
i. Manifest danger to public health.
ii. Unfavourable therapeutic risk - benefit ratio.
iii. Therapeutic inefficacy.
31

32. b) Upon finding that any piece of information provided in the sanitary registration has
been proved to be false.
c) Upon failure to overcome the objections for suspension within the term fixed for such
purpose.
ARTICLE 60 - The holder of the cancelled or suspended sanitary registration shall be responsible
for taking the necessary measures to collect, destroy or denaturate, as required by the Institute,
all pharmaceutical units in storage on the premises or distributed according to current regulations
to other pharmaceutical and healthcare facilities, and for informing users who could potentially
use the concerned product.
ARTICLE 61 - The suspension and cancellation of a sanitary registration shall be determined by the
Institute by means of a substantiated decision notified to the holder.
ARTICLE 62 - Notwithstanding the provisions of article 59, the Institute may cancel a sanitary
registration after conducting relevant preliminary investigations, in addition to penalties imposed
pursuant to the provisions of article 174 of the Sanitary Code.
SECTION 6
SANITARY REGISTRATION AMENDMENTS
1. Technical and sanitary aspects
ARTICLE 63 - Amendments to the sanitary registration of a pharmaceutical drug may be produced
upon a resolution of the Institute, ex officio, or at the request of the holder.
ARTICLE 64 - The Institute may request, by means of a substantiated decision, to introduce
amendments to the registration within a certain period of time to guarantee the quality, safety
and efficacy in the use of one or more pharmaceutical drugs when on the basis of scientific
information from the World Health Organization or foreign or international bodies or
organizations, or arising from its own research, the Institute has the conviction that some of the
authorized use conditions poses a risk to their safety and efficacy.
ARTICLE 65 - Upon the holder's request and by means of a resolution, the Institute may accept
analytical, technical, and legal amendments including the following:
1. Expression of the formula, including the composition of excipients.
2. Specifications of the finished product, methods of control, and effectiveness period.
3. Presentation, content, type of container and additional items or devices for
administration. In the event of the primary container having been modified, the
corresponding stability tests shall be additionally required, if applicable.
4. Retail conditions.
5. Name and graphic label.
32