Launching medicinal products in Europe
Every year, competent authorities in the EU grant numerous new marketing authorizations for medicinal products. As an example, in 2020, the European Medicines Agency (EMA) recommended 97 new medicines and 39 new active substances for authorization.
Although the process for obtaining marketing authorization is widely documented through guidances and directives on health authority websites, the launch process is not centrally described and local requirements may vary from one country to another. This is a challenge for pharmaceutical companies, which have gone through a complex registration process and want to launch their newly registered medicinal products as soon as possible.
What does a successful launch entail?
To successfully launch in the EU, companies need to have the relevant information, know the requirements in the pre-approval and post-approval phases, which steps to follow in each EU country, and what specific country requirements they must follow.
For example, Germany is often the first EU launch country, as reimbursement is automatic for EMA-approved drugs. Before launching in Germany, companies need to follow several key steps and can save time by completing these before receiving final marketing approval. These include:
* Registering at Informationsstelle für Arzneispezialitäten – IFA GmbH and requesting a Pharmazentralnummer (PZN), or national reimbursement number. https://www.ifaffm.de/
* Preparing an SmPC or draft including relevant information and contacting Rote Liste Service GmbH/Fachinfo-Service three weeks before launch. They will prepare an SmPC in a format that can be presented to Healthcare Professionals.
After receiving marketing authorization approval, companies should:
- Review and release the German SmPC in the format for healthcare professionals, which will then be published at fachinfo.de
- Initiate, review, and approve initial artworks
- Prepare the abbreviated SmPC for marketing materials
France is another country where there are specific requirements and steps to be followed to launch a new product. In addition to the steps related to post-approval applicable in all the countries, companies must also:
- Request key information for the bluebox (the boxed area for information specific to the member state) from the French health authority (Agence Nationale de Sécurité des médicaments), including: CIP code (a national code specific to France), local distributor, classification of the list of poisonous substances, level of pictogram for safety instructions (such as use when pregnant or driving warnings).
- Prepare reimbursement steps, which are managed in two phases :
- An initial dossier is submitted to HAS (Haute Autorité de Santé) to obtain the reimbursement rate and medical service level,
- A second dossier is submitted to CEPS (Comité Economique des produits de Santé) to obtain the price of the product. More information is available on the official websites https://solidarites-sante.gouv.fr/ministere/acteurs/instances-rattachees/article/ceps-comite-economique-des-produits-de-sante and https://www.has-sante.fr/
- Translate the patient leaflet into braille. There are organizations that can assist companies to prepare documents in braille if required.
Depending on the disease the treatment targets, some products may be eligible for France’s early access program. Recently, steps have been taken to simplify the submission process, while also improving rigor around the collection of patient data.
Another country with special requirements is Italy.
Within 60 days from the date of the publication of the summary of the European Commission decision in the European Official Journal, drugs are temporarily classified by AIFA as class “C-non-negotiated” (Cnn), i.e. medicines not yet evaluated for reimbursement by the National Health Service/System.
Marketing authorisation holders (MAHs) could also decide to start launching a new product classified as a C (nn) in the Italian market without waiting for the outcome of the process of negotiation for the price and the reimbursement classification with AIFA, but the cost of such product will be totally borne by end-user (patient or hospital). At the end of the negotiation process, a national Decree of price and reimbursement classification will be issued in the Italian Official Journal by AIFA.
In both scenarios, before starting to market a new product in the Italian market, MAHs must fulfil several national requirements: notify the start date of commercialization to AIFA, pharmacists and relevant associations; update the national medicinal database; make available/carry out an authorized German translation of the package insert leaflet and labels to be compliant with bilingualism requirements; and order Bollinos from Istituto Poligrafico e Zecca dello Stato (a self-adhesive label to be placed on the back of all commercial boxes, as required by the national traceability system for drugs).
In all countries, the Falsified Medicine Directive is another key consideration for products that receive marketing authorization in the EU, and companies must consider serialization steps before launch.
Launching medicinal products in Europe is a complex process and it is important to review and understand country-specific requirements. PLG offers a variety of services to prepare companies for successful regulatory and launch strategies. Contact us to learn more.