TITLE VII

WHOLESALE DISTRIBUTION AND BROKERING OF MEDICINAL PRODUCTS
Article 85b
1
Persons brokering medicinal products shall ensure that the brokered medicinal products are covered by a marketing authorisation granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive.
Persons brokering medicinal products shall have a permanent address and contact details in the Union, so as to ensure accurate identification, location, communication and supervision of their activities by competent authorities.
The requirements set out in points (d) to (i) of Article 80 shall apply
mutatis mutandis
to the brokering of medicinal products.
2
Persons may only broker medicinal products if they are registered with the competent authority of the Member State of their permanent address referred to in paragraph 1. Those persons shall submit, at least, their name, corporate name and permanent address in order to register. They shall notify the competent authority of any changes thereof without unnecessary delay.
Persons brokering medicinal products who had commenced their activity before
2 January 2013
shall register with the competent authority by
2 March 2013
.
The competent authority shall enter the information referred to in the first subparagraph in a register that shall be publicly accessible.
3
The guidelines referred to in Article 84 shall include specific provisions for brokering.
4
This Article shall be without prejudice to Article 111. Inspections referred to in Article 111 shall be carried out under the responsibility of the Member State where the person brokering medicinal products is registered.
If a person brokering medicinal products does not comply with the requirements set out in this Article, the competent authority may decide to remove that person from the register referred to in paragraph 2. The competent authority shall notify that person thereof.
Inserted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).
Substituted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).