The impact of Brexit on the pharmaceutical industry
At the European Union (EU) membership referendum held in 2016, it was decided that the United Kingdom (UK) would leave the EU in a withdrawal process known as “Brexit”. Following the activation of Article 50 of the Treaty of Lisbon, an official two-year withdrawal procedure was initiated, whereby the UK would finally leave the EU on 29 March 2019 after 45 years of membership.
Due to the substantial incertitude relating to the particulars of the withdrawal agreement, marketing authorisation holders (MAHs) of centrally authorised medicinal products must in due course consider the possible legal consequences. Therefore, MAHs of centrally authorised medicinal products should transfer the marketing authorisation to MAHs established in the Union (European Economic Area, EEA).
As a consequence of Brexit, MAHs of medicinal products authorised in a mutual recognition procedure (MRP) and decentralised procedure (DCP) where the UK is the reference member state (RMS) should designate a new RMS among the EU member states.
The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) has announced its capacity to take up the role of the RMS for medicinal products authorised in the MRP and DCP where the UK acts as the RMS. This implies that HALMED may take up the role of the RMS only for those procedures where it is involved as a concerned member state (CMS).
For nationally authorised medicinal products, MAHs located in the UK must also transfer the marketing authorisation to MAHs established in the EEA.
As a consequence of the UK’s withdrawal from the EU, the pharmaceutical industry will face many challenges that it will need to grapple with during the transition period. The real impact and scope of Brexit will only become visible during the next few years.
Iva Pavić Orlić, MPharm / Regulatory Affairs Associate
Lašćinska cesta 40
Planinska ulica 13/2
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
Tel: +385 1 5588 297
Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)