Brokering

It is important to differentiate brokering from other similar activities like wholesale distribution of medicinal products or the representation of a marketing authorisation holder of a medicinal product.

Medicinal products may be brokered only by a person holding a respective activity licence.

You can find all legal persons that have an activity licence for brokering in Estonia in National registry of activity licences.

Primary requirements for a broker of medicinal products according to the Medicinal Products Act are:

• The wholesale distribution of medicinal products and active ingredients for human use and the brokering of medicinal products for human use must comply with the good distribution practices established on the basis of Article 47(4) and Article 84 of Directive 2001/83/EC of the European Parliament and of the Council.
• A broker of medicinal products must ensure that mediated medicinal products have a marketing authorisation issued by the European Commission or the competent authority of a Member State.
• A broker of medicinal products must immediately inform the State Agency of Medicines about changes in the details of the activity licence.
• The State Agency of Medicines refuses to grant a brokering authorisation where the applicant’s permanent place of business is outside Estonia or where a wholesale distribution authorisation is required for the activity applied for.