Pharma Investment in Romania: Authorisation, Trials, Clawback

Legal position as at: 24 October 2026

Placing medicines on the Romanian market, running clinical trials in Romania or acquiring a local manufacturer or distributor all rest on the same legal foundations: Title XVIII of Law 95/2006 on healthcare reform, the directly applicable EU pharmaceutical regulations, and a set of national rules on pricing, reimbursement and the quarterly clawback contribution. This guide explains how these pieces fit together for a foreign company and where the practical risks lie.

1. The regulator and the legal framework

The competent authority for medicinal products for human use is the National Agency for Medicines and Medical Devices of Romania (ANMDMR) under Law 95/2006. Title XVIII of Law 95/2006 transposes the EU medicines code (Directive 2001/83/EC) and covers marketing authorisation, manufacturing, wholesale distribution, labelling, advertising and pharmacovigilance. EU regulations apply alongside it, notably Regulation (EC) 726/2004 on the centralised procedure, Regulation (EU) 536/2014 on clinical trials and Regulation (EU) 2021/2282 on health technology assessment.

2. Marketing authorisation

No medicinal product may be placed on the market in Romania without a marketing authorisation issued by ANMDMR under Title XVIII or an authorisation granted under the centralised EU procedure (Directive 2001/83/EC, art. 6(1), transposed by Title XVIII). Additional strengths, pharmaceutical forms, routes of administration and presentations, as well as variations and extensions, must also be authorised and form part of the same global marketing authorisation.

The routes available are:

• Centralised procedure, through the European Medicines Agency, mandatory for certain product categories and resulting in an authorisation valid throughout the EU;
• Decentralised and mutual recognition procedures, where Romania acts as reference or concerned Member State;
• National procedure, for products intended only for the Romanian market.

Member States must ensure that the national procedure is completed within a maximum of 210 days from the submission of a valid application (Directive 2001/83/EC, art. 17(1), transposed by Title XVIII of Law 95/2006). In practice, the timetable depends heavily on the quality of the dossier and on how quickly questions are answered.

The marketing authorisation holder remains responsible for placing the product on the market; appointing a local representative does not relieve it of legal liability. Many foreign holders appoint a local representative, defined in the law as the person designated by the holder to represent it in Romania.

3. Regulatory data protection

Generic applicants may rely on the reference product's preclinical and clinical data only once the reference product has been authorised for at least eight years in Romania, another Member State or the EU. A generic authorised on that basis may not be marketed until ten years after the initial authorisation of the reference product, and this period may be extended by one year where, within the first eight years, the holder obtains a new indication bringing significant clinical benefit (Directive 2001/83/EC, art. 10(1)). This is the familiar 8+2+1 scheme of EU law. Patent and supplementary protection certificate rights, governed by separate legislation including Regulation (EC) 469/2009, apply independently of it.

4. Manufacturing and wholesale distribution

Manufacturing and importing medicines require a manufacturing authorisation and compliance with good manufacturing practice, which ANMDMR verifies through inspections. Wholesale distribution, meaning the procurement, holding, supply or export of medicines other than supply to the public, is a separately authorised activity, subject to good distribution practice and to public service obligations. These obligations require distributors to maintain an adequate range of medicines and to deliver promptly across the area they serve.

Every product with safety features must be verified through the national medicines verification system operated by the Romanian Medicines Serialisation Organisation, connected to the European hub. In an acquisition, the manufacturing and distribution authorisations, the GMP and GDP inspection history and the serialisation compliance record are core due diligence items.

5. Clinical trials under Regulation (EU) 536/2014

Clinical trials in Romania are governed by the EU Clinical Trials Regulation, which became applicable on 31 January 2022. The transition period ended on 31 January 2025; since then, all clinical trials in the EU, including those that started under the old Directive, must run under the Regulation through the Clinical Trials Information System (CTIS).

Government Emergency Ordinance (OUG) 29/2022 sets out the national institutional framework for applying the Regulation. Applications are submitted once, through CTIS, and assessed in a coordinated EU procedure. In Romania, ANMDMR handles the assessment for the national authority, and the national bioethics committee for medicines and medical devices gives the ethics opinion. Part II of the assessment (informed consent, recruitment, site suitability, insurance and compensation) is national, and sponsors should prepare the Romanian-language documents and site agreements early.

Practical points for sponsors and CROs:

• clinical trial agreements with hospitals usually involve both the institution and the investigators, and public hospitals have their own approval processes;
• insurance or indemnity for trial participants must meet national requirements;
• transfers of trial data outside the EU must meet the GDPR requirements.

6. Pricing and reimbursement

Prices of prescription medicines are regulated: the Ministry of Health approves maximum prices under a methodology adopted by ministerial order. Inclusion in the list of medicines reimbursed under the national health insurance system follows a health technology assessment carried out by ANMDMR and a decision adopted by the Government. For certain products, inclusion and reimbursement are conditional on cost-volume or cost-volume-outcome contracts with the National Health Insurance House (CNAS), whose consumption is treated separately for clawback purposes (OUG 77/2011, art. 12).

Since 12 January 2025, joint clinical assessments under the EU HTA Regulation have applied to new oncology medicines and advanced therapy medicinal products; national assessments, including Romania's, must give due consideration to the joint reports.

Pricing approvals, list updates and the methodology are changed frequently. Market access plans should be built on the texts in force at the time of submission.

7. The clawback contribution (OUG 77/2011)

Marketing authorisation holders, directly or through their legal representatives, must pay a quarterly contribution on medicines financed from the National Health Insurance Fund and the Ministry of Health budget, covering outpatient prescriptions, hospital use, national health programmes and dialysis services (OUG 77/2011, art. 1(1)).

Under the text currently in force, since the third quarter of 2023 the contribution has been calculated separately for two categories (art. 3^8):

• Type I medicines, broadly innovative products authorised on their own data (including paediatric-use authorisations) for which no generic or biosimilar is marketed in Romania in the last month of the quarter: 25% of the value of centralised consumption, net of VAT;
• Type II medicines, which include generics and any products outside type I: 15% of that value.

ANMDMR classifies products into the two categories, and the list is approved quarterly by order of the Minister of Health (art. 3^8(3)). The contribution is administered by the National Agency for Fiscal Administration (ANAF) and is treated as a tax obligation (art. 5(1) and (2)), which means tax procedure rules, interest and penalties apply to late payment.

The clawback rules have been amended many times since 2011, so the applicable percentages and categories should be checked for each quarter. For a new market entrant, the clawback is a fixed part of the Romanian margin and should be modelled from the start.

8. Foreign investment screening

Since March 2026 the pharmaceutical sector, including research, development, production, distribution and supply of medicines, medical devices and active substances, is listed as a sensitive domain for acquisitions of assets (OUG 46/2022, art. 2^1, introduced by OUG 17/2026). Authorisation is required where an investment falls within the security fields of CSAT Decision 73/2012 and exceeds 5,000,000 euro (art. 3(1)), and smaller investments may be called in where they could affect security or public order (art. 3(2)). Whether a given transaction must be filed should be assessed case by case. The Romanian regime also covers investors from the EU. An examination fee of 5,000 euro is payable when the request is filed (Competition Law 21/1996, art. 31^2(1)). Acquisitions of manufacturers, distributors and pharmacy chains should include the screening analysis in the deal timetable.

9. Entry routes and a practical sequence

Foreign companies typically choose between:

• holding the marketing authorisation abroad and appointing a local representative;
• setting up a Romanian subsidiary that acts as representative and, if needed, as distributor;
• acquiring a local manufacturer or distributor.

A workable sequence is: choose the regulatory route for each product; set up the local presence and the pharmacovigilance system; obtain the price approval; prepare the reimbursement dossier; register for the clawback contribution; and, for acquisitions, complete the screening filing and the regulatory due diligence before closing.

When to get legal advice

In the Romanian pharmaceutical market, commercial results depend on regulatory steps that are easy to underestimate: price and reimbursement procedures, the quarterly clawback, distribution obligations and, increasingly, investment screening. Our practice advises companies in the sector on corporate structuring, commercial contracts and acquisitions.

This article is general information on the legal position at the date shown and is not legal advice for a specific case. For advice on your project, please write to us at