Generic Medicinal Products

Elite pharma lawyers

advising on generic

medicinal products

Our generic medicinal products team provides legal and regulatory advice and assistance to the generic sector on new and existing generic medicinal products. Our team comprises generic medicinal product lawyers and regulatory experts with substantial expertise advising generic companies in this sector.

One of our regulatory experts is a generic pharmaceutical company with MHRA approval. This company

Holds GMP and GDP certification
Has approvals to import both APIs and Finished Drugs from outside the UK
Have Manufacturing and Importation Authorisation (MIA)
Have Wholesale Distribution Authorisation (WDA) for import and sales of products in the UK

To place a generic medicinal product on the UK market you must hold a Marketing Authorisation from the MHRA. A Marketing Authorisation for a generic medicinal product is granted on the basis that a company can ensure continuous supply of a product of quality strictly in accordance with the dossier and current Good Marketing Practice. There is an obligation on a Marketing Authorisation Holder (MAH) to ensure that the MAH is compliant with current legislation otherwise the Marketing Authorisation could be withdrawn.

Generic medicinal products contain the same quantity of active substance(s) as the Reference Medicinal Products for which marketing authorisations were obtained. The key allowable differences between the Reference Medicinal Products and the generic medicinal products are the appearance (such as colour or shape), the name of the medicinal products and packaging.

In the UK, section 48 of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 regulates Reference Medicinal Products for new generic medicines or other abridged marketing authorisation applications through the MHRA for the following:

Products that are, or have been, authorised for at least 8 years in the UK (including those authorised by conversion from EU marketing authorisations); and
Products that had an EU marketing authorisation on 1 January 2021 but which did not convert into Great Britain marketing authorisations as the holder opted out of that process.

Data and market exclusivity period entitlements for reference medicinal products approved before 1 January 2021 continue to apply in the UK.

Our Services

Our legal and regulatory services to the generic sector include:

Legal Services

Corporate Transactions
Drafting, reviewing and revising Technical Contracts
Compliance with British Pharmacopoeia
Data and Market Exclusivity
Drug Tariff Reimbursement Prices
Due Diligence
Import and Export Regulatory issues
Intellectual Property
Joint Ventures
Labelling and Packaging
Marketing Authorisations
Manufacturing Authorisation
Marketing Authorisation (legal)
Supply Chain
Technical Transfer
Wholesale Distribution Authorisation

Regulatory

Advising and assisting with bringing new Generic Products to Market utilising Technical and Commercial expertise

Assist with Implementation of a proper Document Approval and Change Control System
Assist Marketing Authorisation Holder with Managing and Controlling Supply Chain including Flow and Traceability
Marketing Authorisation
- EC Decision Reliance Procedure
- National Procedure
- Innovative Licensing and Access Pathway (ILAP)
- MR/DC Reliance Procedure
- Rolling review
- Renewal Advising on the suitability of supporting documentation
New or update to Active substance master files applications (dossier advice)
Paediatric investigation Plan
Review of Quality Systems (clear Procedures Documents and Standard Operating Procedures)
Review Non-clinical Documentation for Suitability from a Regulatory perspectives
Regulatory Management and Compliance
Risk Management Plan
Summary of product characteristics (SmPC) and leaflet
Wholesale Distribution Authorisation