5 Steps To Register Medicine in Serbia (The Briefest, Most User-Friendly Guide Ever)

To register a foreign medicine in Serbia, you need to follow the registration procedure set by the Serbian Medicines and Medical Devices Agency (ALIMS).

Here are the general steps involved in the registration process:

You need local representation

1. Appoint a local representative: Foreign pharmaceutical companies need to appoint a local representative who will act as a contact person for the company in Serbia.

The local rep should submit an application

2. Submit the application: The application for registration of a foreign medicine needs to be submitted to ALIMS along with all necessary documents. The application needs to be in Serbian language and should include information about the medicine’s composition, manufacturing process, quality control, clinical trials, and other relevant details.

You settle fees

3. Pay the fees: The registration process involves payment of certain fees, which can vary depending on the type of medicine being registered.

ALIMS evaluates the application

4. Evaluation process: ALIMS evaluates the application and performs a scientific review of the medicine’s safety, efficacy, and quality. This evaluation process can take up to 210 days.

ALIMS approves the medicine registration

5. Approval: If the medicine meets all the necessary requirements, ALIMS approves the registration and issues a marketing authorization. The marketing authorization is valid for five years and can be renewed after that.

PS. It’s important to note that the registration process can be complex, and it’s recommended to seek the assistance of a local regulatory expert or consultant who can guide you through the process and ensure that all necessary requirements are met.

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Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your AK STATT representative, or other competent legal counsel.