B6: Medicines Licensing Flashcards
why do we need a license?
-Illegal to manufacture, assemble, import or distribute ..… without a licence, certificate or exemption
-Provides standards of quality and safety
-Regulation and licensing introduced under the Medicines Act
licensing organisation is?
Medicines and Healthcare products Regulatory Agency (MHRA)
what is Marketing Authorisation (MA)?
-Name given to the licence with full regulatory approval in UK
-Places restrictions on products → can’t use in everyone for everything!
-Defines the legal classification of the medicine (POM, P, GSL)
MA allows:
-sale, supply, import and export of a medicinal product
-procurement for sale, supply, export, manufacture or assembly
medicines pathway?
ONE NOTE
Describe clinical trial authorisation (CTA)
-Application to MHRA for CTA (licence for clinical trials)
-Permits use of a medicinal product in trials/tests
-CTA also permits (for the purposes of a trial):
-sale or supply of a medicinal product
-manufacture or assembly for sale or
supply
-import into the UK
Describe early access to medicines scheme (EAMS)
-Gives patients with life threatening or seriously debilitating conditions, access to medicinal products that are not licensed, where no suitable alternative exists
-Permits ordering, manufacture and distribution if MHRA are satisfied certain conditions are met
-Requirements for pharmacovigilance (safety monitoring)
-Advertising is prohibited
MA application?
-licensing authority considers: safety, quality, efficacy
-Creates Summary of Product Characteristics (SmPC)
-SmPC underpins BNF drug information and forms basis of PIL
MA Abridged applications?
For generic medicines
MA applications under the International Recognition Procedure (IRP)?
-For products with regulatory approval in another country/territory
-Specified countries only (EU/EEA, US, Canada, Australia, Switzerland, Japan, Singapore)
-Shortened assessment but MHRA retains right to reject applications
How long is MA valid for?
-MA is initially valid for up to a period of 5 years
-After renewal, valid indefinitely
-Licensing authority can revoke, suspend or vary a licence at any time due to safety concerns
-Initiates post-marketing surveillance
Describe manufacturer’s licence (MIA)
-Required for manufacturing or assembling relevant products
Assembly = filling, packing & labelling the container
-Manufacturers licence needed for a process resulting in a medicinal product-but not for manufacturing a substance to supply to someone else to make a medicinal product!
how to obtain a manufacturer’s licence?
-Licensing authority takes various criteria into account: See D&A p170-171
-Demonstrate Good Manufacturing Practice (GMP), Qualified Person (qualification, experience)
-MIA only authorises the manufacture of a medicinal product if:
the licence holder also has the MA, or
the licence holder is making it to the specification of the MA
general labelling requirements?
-Be legible, comprehensible and indelible
-Be in English
-Include standard labelling particulars (specific info)
-From 2025 – “UK only” (if marketed in UK
Package leaflets must:
-Be legible, clear and easy to use
-Be written in accordance with SmPC
-Include specified particulars (specific info)
Standard Labelling Particulars for Medicinal Products?
-Detailed requirements for labelling of containers / packages
-Name of product in Braille on outer packaging
-Legal classification (POM, P in a rectangle)
-May include symbols, diagrams or pictograms to clarify information (not for promotion)
Describe parallel importing- also MIA licence
-Modified (MA) licence application for a product imported from an approved country (mostly EEA countries)
-Must be a version of a product with a full UK MA
-Over-labelled in English with general labelling requirements and English package leaflet
What is wholesale dealing?
-Sale of a medicinal product to a person who buys it to:
sell / supply to someone else
administer / cause to be administered to someone else
-In the course of a business carried on by the purchaser
Describe wholesale dealer’s licence
-Licensing authority takes various criteria into account: (see D&A p324-325)
-GDP (Good Distribution Practice)
-Responsible person, Knowledge and experience of activities undertaken
-Licence known as: Wholesale Distribution Authorisation (WDA)
exemptions for MIA or WDA licence?
one note
What is a herbal remedy?
-From dried / crushed / powdered plant materials; may include water in preparation
-Label only states actual contents
-No recommendation for use
What is a herbal medicinal product?
-Herbal substance (i.e. just plant material, unprocessed) or
-Herbal preparation (processed e.g. extracted, distilled, concentrated, etc) to produce a liquid form (but not diluted)).
-No other active ingredient
-Includes recommendation for use e.g. St John’s Wort Tablets for low mood
Herbal medicinal product must be either:
-Licensed medicine (with Marketing Authorisation - MA) if makes a medicinal claim; or
-Traditional Herbal Medicinal Product (with Traditional Herbal Registration - THR)
ONE NOTE
