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MHRA manufacturing licence
- 1. MHRA licence Manufacturing Contact : gxpmatters@gmail.com
- 2. Content • Purpose of manufacturing licence • Types of License • Manufacturing licence • Manufacturing licence activities • Application for manufacturing licence • Licence variation application • Application processing time • Licence holder obligation • Withdraw application • Terminate licence
- 3. Purpose of manufacturing licence • A manufacturer licence requires to make, assemble or import human medicines. Licence issued by the National regulatory authority e.g., MHRA, EMA,ASNM,ANVISA • To comply with good manufacturing practice (GMP) to qualify for a manufacturer licence through regular GMP inspection by the national regulatory authority
- 4. Types of License • MIA : Manufacture/importation of licensed medicinal products for human use • MS : Manufacture/importation of unlicensed (Special) medicinal product for human use • MIA(IMP) : Manufacture/importation of investigational medicinal product for human use • ManA : Manufacture/importation of licensed medicinal product for veterinary use • ManSA : Manufacture of unlicensed (Special) medicinal product for veterinary use • MeAT : Manufacturer's licences for exempt advanced therapy medicinal products
- 5. Types of License • WDA (H) : Wholesale distribution of medicinal products for human use • WDA (V) : Wholesale distribution/importation of medicinal products for veterinary use • BEA : Blood establishment authorisations • NOP : Non-orthodox practitioners • Broker registration • Active substance manufacturer, importer or distributor registrations • certificates of Good Manufacturing Practice (GMP) • certificates of Good Distribution Practice (GDP)
- 6. Manufacturing licence • MIA : Manufacture/importation of licensed medicinal products for human use • MIA(IMP) : Manufacture/importation of investigational medicinal product for human use • MS : Manufacture/importation of unlicensed (Special) medicinal product for human use
- 7. Manufacturing licence activities • Manufacturing • Assembly • Import from a third country • Export to a third country • Batch certification
- 8. Application for manufacturing licence • Application forms for manufacturing/special licence are available on MHRA website (PCL portal) • Applicant should have Site Master File (SMF), guidance for SMF are EudrLex, PIC/S • Licence can issue after satisfactory compliance inspection • Authority may refuse or grant licence for another category which are on applied for. Authority notify to applicant with a proposal and justification of proposal, give applicant a period of not less than 28 days to respond • Any changes on licence should made by submitting variation application
- 9. Licence variation application • 2 types of changes: • Identical changes to number of licences • Requesting multiple changes at the same time • Change of ownership Standard Administrative Business process named person(s) Site address Telephone number and email addresses Contact persons Company name Add/delete listed product on licence
- 10. Application processing time • MHRA may take 90 working days to process new application • Variation to licence may take 30 working days but can extend to 90 days if inspection require • new applications for registration as Active Substance manufacturers, importers and distributors take 60 working days but can take to 90 working days if inspection require
- 11. Licence holder obligation • Comply with conditions are set out in regulations 37- 41 of the Human Medicines Regulations 2012 • Comply with the principles and guidelines of good manufacturing practice e.g., EudraLex volume 4, Orange guide • Comply with conditions set out in regulations 43 – 45 of the Regulations including good distribution practice
- 12. Withdraw application • 90% of the application fee will be refunded if applicant withdraw your application before the inspection for manufacturing licence • 50% of the application fee will be refunded if the inspection is not conducted for manufacturing licence • full inspection fee will be payable, unless applicant withdraw the application for the licence at least 15 days before the date on which the inspection
- 13. Terminate licence • Applicant to complete ‘request to terminate a licence/authorisation/registration’ form and email to PCL. • No fee for terminating a licence, • To avoid the annual service fee, applicant must make the request before 31 December.
Editor's Notes
- Hello Everyone, Today I am going to talk about MHRA licence particularly about manufacturing licence
- Today I will talk about
- MHRA – Medicine and Healthcare product regulatory agency EMA – European medicine agency ASNM – The national agency for the safety of medicine and health product France ANVISA – Brazilian health regulatory agency
- There are various type of licences covers medicine for human and veterinary medicine manufacturing and distribution.
- Certificate of GMP , GDP issue by national authority after satisfactory inspection.
- Focusing on manufacturing licence for this presentation MIA - Manufacture and/or assemble licensed medicinal products, including export to a country outside the European economy zone (EEA), Import licensed medicinal products from countries outside the EEA MIA (IMP) - Manufacture investigational medicinal products for use in clinical trial MS - Manufacture unlicensed medicines ‘specials’. Import unlicensed medicinal products from outside the EEA
- Manufacturing - A Manufacturer’s Licence is required for both total and partial manufacture, the various processes of dividing up, packaging or presentation and for import from a third country Assembly - in relation to a medicinal product, means enclosing the product (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied, or, where the product is already enclosed in the container in which it is to be sold or supplied, labelling the container before the product is sold or supplied. The over-labelling of medicinal products is an assembly activity and is therefore licensable. Importing third country other than EEA, To export manufactured medicine Batch certification - in relation to medicinal products, concerns the activities conducted by a Qualified Person, in determining that a batch of a finished medicinal product is certified within the EEA before release for sale or supply in accordance with the requirements of the marketing authorisation. MHRA can issue solely licence for batch certification only for product which applicant holding Marketing authorisation MIA holder can store, distribute medicinal product without additional WDL, however certain obligation to meet
- SMF - specific and factual information about the production and/or control of the pharmaceutical operations to be carried out. Guidance for SMF are EudraLex , PIC/S Variation application forms are on MHRA website and appropriate fees select from form F2, fill out variation related form from 1V to 15V. e.g. 15V to update QP, QC, PM, 1V is cover letter with all application
- There are 2 types of licence variation applications. Standard Administrative Standard variation include A standard variation may require an inspection and you may have to pay an inspection fee as well as the variation fee. Administrative variation include Making identical changes to a number of licences If applicant need to make exactly the same change(s) to a number of different licences (with the same licence number), the licence that has the higher fee will be charged at the full rate and the remaining licences at 50%. Requesting multiple changes at the same time MHRA only charge per submission and not per change so if applicant make a number of changes, applicant will only have to make a single payment for the change which attracts the higher fee. Change of ownership Applicant must apply for a change of ownership when a sole trader becomes a limited company and the new company continues manufacturing or wholesale distributing a medicinal product. Use the Portal to register the new company and submit a new application, clearly stating change of ownership from company A to company B, once this has been processed the old WDA(H) Authorisation will be terminated. When completing the new application, only the company name, name of the licence holder and site name may change, to make any other changes you must apply for a variation after the new application has been approved.