Regulatory affairs

Our service offering covers the entire approval process for your parallel-imported drugs and generics.

In order to distribute a drug in Germany, a national marketing authorization is required.

We are in close contact with the responsible federal authorities and can support you in the best possible way to fulfill all requirements for the approval of your medicinal products.
About us
Every drug must be approved by the Federal Institute for Drugs and Medical Devices (BfArM) in accordance with § 21 in conjunction with § 73 of the German Medicines Act (AMG) before it can be distributed on the German market. And this applies regardless of whether the drug is a generic or has already been approved in another EU country.

The approval process is often very difficult and time-consuming for many pharmaceutical companies. The reason for this is that in order to obtain approval for a drug in Germany, a large number of documents must be submitted to prove the efficacy, safety and quality of the drug.

In addition, there are strict requirements for the use and expert information and the labeling texts for the approval in accordance with the German Medicines Act. For example, the pharmaceutical company must be able to demonstrate with the help of a readability test that the text of the package insert can be easily understood by patients. Nevertheless, it is often difficult to present the large amount of required and often complicated information in a simple way.

As a leading specialist logistics provider in the handling of narcotics with a total of more than 25 years of expertise, as well as our wholesale and manufacturing/import license, PS Pharma Service GmbH is your perfect partner to support you in the approval of your drugs.

Benefit from our many years of experience in the field of drug registration.

Whether in the European procedure (mutual recognition procedure, DCP) with Germany as "reference member state" or with other EU member states in this function, whether local marketing authorization only in Germany or in parallel in several countries, whether notification of variation or extension of marketing authorization, whether PSUR or report according to § 31 para. 2 AMG - our experience covers all areas!
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APPROVAL OF GENERICs

Generic drugs

For the approval of a generic drug, the performance of own preclinical and clinical trials can be waived under certain conditions. Of utmost importance, however, is consistency with the reference drug. The generic drug must be essentially the same as the reference drug, i.e. the same active ingredient, dosage form and bioavailability.

In addition to the documents demonstrating substantial comparability, the applicant must submit the administrative data, pharmaceutical quality data, and expert summary reports.
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APPROVAL OF PARALLEL IMPORTED MEDICINAL PRODUCTS

Parallel imports

A parallel imported drug is when a drug that is already approved in another EU country is purchased by an external company and imported into Germany. Parallel-imported medicinal products must also be approved in Germany before they can be placed on the market by the importer.

For approval, parallel importers must fulfill various requirements imposed by the authorities. Among other things, they need a manufacturing authorization (§ 13 AMG) for the labeling of the containers in German and the subsequent release, a step-by-step plan officer (§ 63a AMG) as well as an information officer (§ 74a AMG). We at PS Pharma Service Ltd can fulfill all these requirements.

We are here for you!

Do you have questions or need more information? PS Pharma Service GmbH stands for personal support by our experts and the best customer service. Get in touch - we will be happy to advise you.
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