PZN: here’s how it works
The pharmaceutical registration number (PZN) is the national identification key for products sold in pharmacy division according to the declaration of obligation, in particular according to § 131 Abs. 4 SGB V; excl. individual imports.
Every eight-digit code describes exactly one article type, with a particular designation, packaging size (quantity/unit) and dosage form of a producer. Correspondingly, it is necessary to apply for different PZN if the package content is different.
How the audits work
The allocation of the PZN is made by the information office for medical specialty ”Informationsstelle für Arzneispezialitäten”(IFA). The numbers are handed out sequentially after a central audit of the submitted documents.
These audits take place twice a month.
For the Admission of a product it has to be freely marketable in Germany, for that reason it has to fulfill every requirement and regulation.
For a fast implementation it is necessary, to be well informed about the German and European laws and standards; as well as the pharmacy law and if appropriate the medical products law. It is recommended to check conformity to these standards early to avoid subsequent changes on basis of the IFA-Regulations.
Early-stage consulting is key
Consulting at an early Stage of Product development can save much time and ensure a quick Market access.
The International valid „Pharmacy Product Number” (PPN) can also be requested with our help on the same way.
Our outstanding experience in the area of Market Access Consulting guarantees you a fast and secured receipt of a pharmaceutical registration number. We are your gateway to one of the biggest health care markets in the world.