BfArM
Federal Institute for Drugs and Medical DevicesCompetent for granting marketing authorisations for most medicinal products, and runs national, decentralised, mutual-recognition and centralised-procedure work on the German side.
For some products the route is decided for you by EU law. For the rest it is a strategic choice with real commercial consequences — how many markets you open at once, how long it takes, and which German authority reads your dossier. Choosing badly is not fatal, but it is slow, and slow is expensive.
There are four ways to get a medicine authorised for the German market. The centralised procedure (EMA) is mandatory for biotechnology-derived products, biosimilars, ATMPs, orphan medicines and new active substances in areas such as cancer, HIV/AIDS, diabetes and neurodegenerative disease — and gives one authorisation valid across the EU. Otherwise you choose: decentralised (several member states at once, nothing authorised yet), mutual recognition (already authorised somewhere, extend it) or purely national (Germany only). In Germany the assessing authority is BfArM for most products and the Paul-Ehrlich-Institut for vaccines, sera, allergens, blood products and advanced therapies. The authorisation lets you sell. AMNOG decides what you are paid.
Companies arrive with a plan for the trial and a plan for the price. The authorisation route in between is often treated as paperwork — and it is the decision that sets the calendar for both.
The route determines how many markets you can enter simultaneously, which regulator's questions you answer, whether one national objection can hold up the whole procedure, and when your German launch clock — and with it the benefit assessment — actually starts. It is a commercial decision dressed as a regulatory one.
First establish whether you have a choice at all. For a large share of modern medicines, EU law has already made it.
Work through them in order. The first one often ends the discussion.
One application to the EMA, one Commission decision, one authorisation valid in every EU member state. No choice to make — and no need to repeat the exercise country by country.
The centralised route may still be open to you optionally. Otherwise the answer depends on whether the product is already authorised somewhere in the EEA.
If your product falls in here, the centralised procedure is not an option you weigh — it is the only route.
Under the EU pharmaceutical regulation, the centralised procedure is mandatory for:
There is also an optional centralised route: products representing a significant therapeutic, scientific or technical innovation, or where an EU-level authorisation is in the interest of public health. Worth considering even when not compulsory — a single procedure that opens the whole EEA can beat four national ones.
What each route is for, and what you actually end up holding.
| Route | Use when | What you get | German role |
|---|---|---|---|
| Centralised CP · EMA | Product is in the mandatory scope, or you opt in for innovation / public-health grounds. | One authorisation valid across the EU and EEA. | BfArM or PEI experts participate in the EU assessment; the decision is European. |
| Decentralised DCP | Not yet authorised anywhere in the EEA and you want several markets at once. | Parallel national authorisations in the chosen member states. | Germany can act as reference member state or as a concerned member state. |
| Mutual recognition MRP | Already authorised in one member state; you want to extend to others. | The existing authorisation recognised and mirrored in further member states. | Germany recognises another state's authorisation, or is the one recognised. |
| National Germany only | Germany is the only market you need, now or for the foreseeable future. | A German authorisation only. | BfArM or PEI assesses and grants directly. |
On timing: in the decentralised route the reference member state's evaluation can run up to 210 days, and by day 210 at the latest the concerned member states are to agree the final assessment report — unless one considers that authorisation would pose a serious risk to public health. That last clause is the reason multi-country routes carry a tail risk a national one does not.
More markets in one procedure also means more places a single objection can stop it.
A marketing authorisation cannot be held by a company established outside the European Economic Area. A manufacturer in the US, Japan, Korea or India therefore needs an EEA-established entity — its own subsidiary, or a partner — to be the marketing authorisation holder, and that holder carries the continuing obligations that come with it: pharmacovigilance, batch release oversight, variations, renewals and communication with the authorities.
This is the same structural question that appears at every stage of a regulated entry, under different names: the sponsor's legal representative for trials, the authorised representative for devices, the authorisation holder for medicines. Whoever holds it holds your access — a point we make in local representation, and one worth deciding deliberately rather than by default.
A marketing authorisation is permission to place the product on the market. In Germany that is the beginning of the commercial process, not the end of the regulatory one.
It does not set a price, does not oblige any payer to reimburse, and does not put your product in a hospital or a pharmacy. For a new medicine, the German launch triggers the benefit assessment and the price negotiation that follow — and those decide your actual revenue. Ongoing obligations start at the same moment: pharmacovigilance, a named responsible person, variations and renewals.
Which is why the authorisation route should be chosen with the payer timeline in view, not only the regulator's. An EU-wide authorisation obtained quickly is only an advantage if the evidence behind it will also survive the AMNOG benefit assessment.
Authorised means allowed to sell. It has never meant paid.
We help international manufacturers choose between the centralised, decentralised, mutual-recognition and national routes, work out which German authority they will face, settle the authorisation-holder question, and line the whole thing up against the reimbursement clock that follows.