7 Things You Need For Import & Trade of Healthcare Products in Serbia

To import and trade with healthcare products in Serbia, there are several requirements and regulations that must be met. Here are some of the key components:

Registration

1. Healthcare products must be registered with the Medicines and Medical Devices Agency of Serbia as well as with the Ministry of Health in Serbia before they can be imported and sold. The registration process involves submitting an application, product information, and clinical data for approval.

Quality Standards

1. Healthcare products must meet specific quality standards, such as Good Manufacturing Practice (GMP), to ensure that they are safe and effective for consumers.

Import Permits

1. Importers must obtain an import permit from the Ministry of Health before importing healthcare products into Serbia. The permit is valid for one year and must be renewed annually.

Customs Clearance

1. Healthcare products must go through customs clearance at the border before they can be sold in Serbia. The customs clearance process involves submitting import documentation, paying customs duties and taxes, and complying with import regulations.

Packaging and Labeling

1. Healthcare products must be packaged and labeled according to Serbian regulations. The labeling must include information such as the product name, manufacturer, ingredients, dosage, and expiration date.

Advertising and Promotion

1. Advertising and promotion of healthcare products must comply with Serbian regulations. Advertising must be truthful, not misleading, and must not make unsubstantiated claims about the product’s benefits.

Distribution

1. Healthcare products must be distributed through licensed distributors who are authorized to sell medical products in Serbia.

PS. To import and trade with healthcare products in Serbia, you need to comply with registration requirements, quality standards, obtain import permits, clear customs, comply with packaging and labeling regulations, advertise and promote the products in accordance with the regulations, and distribute the products through licensed distributors. It’s important to work with experienced professionals to ensure compliance with all applicable laws and regulations.

For more information on this or any other legal, tax, or business topic, feel free to write to us at [email protected] at any time or call us at phone number +381113281914 every working day from 08:30 to 16:30.

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.