How to navigate complex European commercialization requirements
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Frederic Pailloux, Pharm.D., M.Sc.
In more complex manufacturing, supply chain and import situations, experience shows it can take as long as two years to prepare – all of which puts huge strain on your quality assurance, commercial and supply chain departments. Adding to this complexity are the different requirements in each European Union Member State – which exist despite efforts to harmonize distribution practices and the requirements from European countries outside the EU/European Economic Area.
To overcome these challenges, companies should prepare a clear short-, medium-, and long-term strategy for their commercialization strategy. First, consider the best location for your EU marketing authorization holder (MAH) and your site of importation (which is not necessarily the same). Next, design your planned supply route and identify partners for the importation, distribution, and commercialization of the product. At each step it is advisable to seek out advice from quality management and compliance experts to risk assess supply chain challenges, taking into account the physical and financial flow of goods.
Proper oversight of your manufacturing sites is paramount to ensure importation, batch testing (where relevant), and QP certification is appropriately managed. Also, make sure the wholesalers or distributors involved hold the necessary operating license(s) – a Manufacturing and Importation Authorization (MIA) and/or Wholesale Distribution Authorization (WDA) [1], as applicable.
There may also be country-specific requirements to consider, such as the French market, which exercises rigorous control of product distribution and lifecycle management within its territory [2].
Beyond the EU
Two key European markets that are outside of the EU, the United Kingdom and Switzerland, also have specific marketing authorization and distribution requirements. In the UK, companies that sell or supply human medicines to anyone other than the patient must have a wholesale distribution license, which is issued by the Medicines and Healthcare products Regulatory Agency (MHRA) [3].
The UK has also introduced a unique role: that of the Responsible Person import (RPi) who is responsible for confirming QP certification and oversight of products imported into Great Britain from countries on an Approved Country for Import list, which, initially, refers to countries in the EEA [4].
For Switzerland, it is a requirement to have a local entity to even apply for marketing authorization, since Swissmedic does not recognize EU approvals [5]. It is also a requirement to have a local WDA supervised by a Responsible Person based in Switzerland who can quickly access the site in case there are any issues with a product that need to be resolved diligently [6].
Despite these complexities, these are valuable markets. Taking the time to plan early and establish a strategy to ensure proper commercialization readiness will allow companies to more successfully navigate these markets and expand their reach.
- Wholesale Distribution Authorisation, EudraGMDP. https://eudragmdp.ema.europa.eu/inspections/view/wda/WDAHomePage.xhtml
- France Public Health Code, Section 1: Scope and definitions (Articles R5124-1 to R5124-15), Legifrance. https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000043761806
- https://www.gov.uk/government/publications/medicines-notes-for-applicants-and-holders-of-a-wholesale-dealer-licence-or-broker-registration/notes-for-applicants-and-holders-of-a-wholesale-dealers-licence-wdah-or-broker-registration
- Acting as a Responsible Person (import). https://www.gov.uk/guidance/acting-as-a-responsible-person-import
- Federal Act on Medicinal Products and Medical Devices, TPA, RS 812.21, Art. 10. https://www.fedlex.admin.ch/eli/cc/2001/422/en#art_10
- Ordinance on Licensing in the Medicinal Products Sector, MPLO, RS 812.212.1 https://www.fedlex.admin.ch/eli/cc/2018/786/en
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