07.03.2023.

Marketing Authorization (MA) for a Medicine in Serbia

If you’re a foreign pharmaceutical company looking to introduce your medicine in Serbia, getting marketing

If you’re a foreign pharmaceutical company looking to introduce your medicine to Serbia, obtaining marketing authorization (MA) for a medicine in Serbia is an essential first step. The Serbian Medicines and Medical Devices Agency (ALIMS) manages the registration process. While it might seem complex, this guide simplifies the process into 5 easy steps to help you navigate each stage smoothly.

1. Appoint a Local Representative

To start, you must appoint a local representative in Serbia. This person will act as your contact with ALIMS and handle all aspects of the registration process. Without a local representative, you cannot proceed with the application. This step is crucial to ensure proper communication and adherence to Serbian regulations.

2. Submit the Application in Serbian

Next, your local representative will submit the application for your medicine’s registration to ALIMS. The application must be in Serbian and should include all necessary information, such as:

Composition of the medicine
Manufacturing process
Quality control measures
Clinical trials and results

Make sure to provide all requested documentation to avoid delays and help the review process move forward smoothly.

3. Pay the Registration Fees

The next step in obtaining marketing authorization (MA) is paying the registration fees. These fees depend on the type of medicine you are registering. To prevent any setbacks, ensure you pay the correct fees. Refer to ALIMS’ guidelines for an accurate breakdown of the payment process.

4. ALIMS Evaluation Process

After your application is submitted and the fees are paid, ALIMS will begin evaluating your medicine. During this stage, ALIMS will conduct a scientific review of the medicine’s safety, efficacy, and quality. This review determines whether your product meets the required standards for approval. Keep in mind that this evaluation can take up to 210 days, so it’s important to remain patient throughout the process.

5. Approval and Marketing Authorization

Once ALIMS has completed the evaluation and if they find the medicine meets all requirements, they will issue a marketing authorization (MA). This authorization gives you the right to legally market your medicine in Serbia. The marketing authorization is valid for five years and can be renewed upon expiry. This ensures that your product complies with Serbian regulations long-term.

How to Ensure a Smooth Registration Process

Obtaining marketing authorization (MA) for a medicine in Serbia involves several important steps, from appointing a local representative to waiting for ALIMS’ approval. By following these five steps, you’ll have a better chance of successfully registering your product and ensuring it enters the Serbian market.

However, navigating the registration process can be challenging due to the complexities of pharmaceutical regulations. For a smoother experience, it’s wise to consult with a local regulatory expert or consultant. They can guide you through the process, ensure that you meet all the necessary requirements, and help speed up the approval of your marketing authorization.

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