Section VII REGULATION ON CIRCULATION OF MEDICINES AND MEDICAL PRODUCTS

 

Article 30

Establishing a Common Market of Medicines

 

 

           The Member States shall establish a common market of medicines within the Union in compliance with the relevant standards of good pharmacy practice based on the following principles:

 

1) harmonisation and unification of the legislation of the Member States in the sphere of circulation of medicines;

 

2) ensuring the uniformity of mandatory requirements for the quality, effectiveness and safety of circulation of medicines on the territory of the Union;

 

3) adoption of common rules in the sphere of circulation of medicines; 4) development and application of identical or comparable research and

 

monitoring methods to assess the quality, effectiveness and safety of medicines;

 

5) harmonisation of the legislation of the Member States in the field of control (supervision) over circulation of medicines;

 

6) exercising licensing and supervisory functions in the sphere of circulation of medicines by the relevant authorised authorities of the Member States.

 

           The common market of medicines shall function within the Union in accordance with an international treaty within the Union subject to the provisions of Article 100 of this Treaty.

 

 

 

Article 31

 

Establishing a Common Market of Medical Products

 

(medical devices and equipment)

 

 

           The Member States shall establish a common market of medical products (medical devices and equipment) within the Union based on the following principles:

 

1) harmonisation of the legislation of the Member States in the sphere of circulation of medical products (medical devices and equipment);

 

2) ensuring the uniformity of mandatory requirements for the efficiency and safety of circulation of medical products (medical devices and equipment) on the territory of the Union;

 

3) adoption of common rules in the sphere of circulation of medical products (medical devices and equipment);

 

4) establishment of common approaches for the creation of a quality assurance system for medical products (medical devices and equipment);

 

5) harmonisation of the legislation of the Member States in the field of control (supervision) in the sphere of circulation of medical products (medical devices and equipment).

 

           The common market of medical products (medical devices and equipment) shall function within the Union in accordance with an international treaty within the Union subject to the provisions of Article 100 of this Treaty.