Jurisdiction(s):
United Kingdom

Key definition

Regulatory data protection definition

What does Regulatory data protection mean? Regulatory data protection is the statutory “data exclusivity” period during which a regulator will not allow a generic or biosimilar applicant to rely on the originator’s pre‑clinical and clinical trial data when seeking an abridged marketing authorisation for a reference medicinal product. It operates alongside, and independently of, patents and SPCs. In practice, the regime follows the 8+2(+1) model: eight years of data exclusivity (no regulatory reliance on the originator’s dossier), followed by two years of market exclusivity (no placing a generic/biosimilar on the market even if authorised), with a possible extra one year for a new therapeutic indication showing significant...

EU and UK regulatory data protection for medicinal products: 8+2+1 rule, global marketing authorisation, orphan exclusivity, OTC/indication extensions, and post‑Brexit (GB/NI) regime and reforms

Published by a LexisNexis Life Sciences expert

Practice notes

Directive 2001/83/EC (the Pharmaceutical Code) introduces a period of data exclusivity starting from the first authorisation of innovative medicinal products, during which the pre-clinical and clinical trial evidence produced to support that approval cannot be relied upon by any applicant seeking a marketing authorisation (MA) for a generic medicine. During this time, such data may not be cited or cross‑referred to by others at all.

Accordingly, data exclusivity provides innovative companies with assurance that the scientific material prepared for the MA of the innovative product is safeguarded and will not be used to evaluate dossiers submitted by makers of generic or biosimilar medicines until the exclusivity enjoyed by the innovative product has expired. This protection is also termed regulatory data protection (RDP).

This Practice Note sets out an overview of the relevant EU rules that govern RDP for MAs covering innovative medicinal products and considers how those rules affect the timing of market entry for generic and biosimilar medicines. It further outlines how RDP is addressed in the UK.

Introduction to the concept of regulatory data protection

An ‘innovative medicinal product’, also known as a ‘reference medicinal product’ owing to its role in the authorisation of later generic or biosimilar...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Elisabethann Wright , BL

Cooley (UK) LLP

Elisabethann Wright specializes in EU law and regulation of pharmaceuticals and medical devices and is regularly sought-after and praised for her knowledge of the legislation, technical competence and commercial acumen. She has been practicing in the life sciences sector for over 35 years in private practice and international institutions. Elisabethann helps clients navigate the process and regulations to place and keep their products on the European Union market through strategic advice, advocacy before institutions and agencies and litigation before EU courts. ...

Fabien Roy

Hogan Lovells

As a partner of our Life Sciences practice, Fabien Roy focuses his practice at Hogan Lovells on advising Clients on European Union and national regulatory matters applicable to medical devices, medicinal products and combination products throughout their entire life cycle. With a practice entirely focusing on complex regulatory issues faced by Life Sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions enabling Clients to focus on their business. Fabien focuses particularly on guiding Clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures, conformity assessment and registration procedures and post-market activities. Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues...

Jane Summerfield

Hogan Lovells

Jane Summerfield is Co-Head of our Life Sciences and Health Care sector and leads the Hogan Lovells life sciences regulatory and commercial practice in London. She advises life sciences companies on a wide range of regulatory matters, including clinical trials, early access, marketing authorisations, manufacturing and distribution licences, CE/UKCA marking, digital health, advertising and marketing activities, HCP compliance, and pricing and reimbursement. Jane also advises on commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing, distribution, services, quality and pharmacovigilance agreements. Jane works with clients to resolve issues with UK enforcement authorities and regulatory bodies, including the Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Medicines Code of Practice Authority (PMCPA) and Advertising Standards Authority (ASA). Jane combines a scientific background with deep regulatory knowledge and a commercial approach, providing "clear responses with business impact"....

Richard Welfare

Hogan Lovells

Richard Welfare focuses on regulatory compliance work within the Commercial Law practice area. Richard works with manufacturing companies to ensure that they comply with legislation and regulatory frameworks, including requirements governing product composition, labeling, packaging and claims, rules relating to advertising and marketing campaigns and other key considerations when launching a product in the EU/UK. Richard has helped clients resolve issues with UK enforcement authorities, including Trading Standards, the ASA (Advertising), MHRA (Medical Devices) and the FSA (Food). Richard has worked with in-house counsel and corporate affairs teams to design and implement public affairs programs and targeted communication strategies, and has worked with companies to design safety programs, following safety or product quality crises. Richard advises clients on the contracting arrangements, providing commercial support to in-house teams. He works on a variety of contracts including those for supply,...

Web page updated on 21/05/2026

Popular documents

Using the Judicial College Guidelines to assess general damages in personal injury claims

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Tomlin orders in England and Wales: CPR guidance on drafting, confidentiality, approval, variation, enforcement, limitation, CCA issues, court-specific requirements, sample wording and precedents

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Precedent: Deed of Surrender of Lease with Optional Premium, Settlement and Release, Landlord, Mortgagee and Guarantor Consents, Reimbursement and HM Land Registry Provisions (England and Wales)

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Precedent Statutory Declaration: Standard Wording under the Statutory Declarations Act 1835

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...