CHAPTER IV U.K. POST-MARKETING AUTHORISATION MEASURES

Section 1 U.K. Union product database

Article 55 U.K. Union database on veterinary medicinal products

1. The Agency shall establish and, in collaboration with the Member States, maintain, a Union database on veterinary medicinal products (‘product database’).

2. The product database shall contain at least the following information:

(a) for veterinary medicinal products authorised within the Union by the Commission and by the competent authorities:

(i)

name of the veterinary medicinal product;

(ii)

active substance or substances, and the strength of the veterinary medicinal product;

(iii)

summary of product characteristics;

(iv)

package leaflet;

(v)

the assessment report;

(vi)

list of sites where the veterinary medicinal product is manufactured; and

(vii)

the dates of the placing of the veterinary medicinal product on the market in a Member State;

(b) for homeopathic veterinary medicinal products registered in accordance with Chapter V within the Union by the competent authorities:

(i)

name of the registered homeopathic veterinary medicinal product;

(ii)

package leaflet; and

(iii)

lists of sites where the registered homeopathic veterinary medicinal product is manufactured;

(c) veterinary medicinal products allowed to be used in a Member State in accordance with Article 5(6);

(d) the annual volume of sales and information on the availability for each veterinary medicinal product.

3. The Commission shall, by means of implementing acts, adopt the necessary measures and practical arrangements laying down:

(a) the technical specifications of the product database including the electronic data exchange mechanism for exchanging with the existing national systems and the format for electronic submission;

(b) the practical arrangements for the functioning of the product database, in particular to ensure protection of commercially confidential information and security of exchange of information;

(c) detailed specifications of the information to be included, updated and shared in the product database and by whom;

(d) contingency arrangements to be applied in case of unavailability of any of the functionalities of the product database;

(e) where appropriate, data to be included in the product database in addition to the information referred to in paragraph 2 of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 56 U.K. Access to the product database

1. The competent authorities, the Agency and the Commission shall have full access to the information in the product database.

2. Marketing authorisation holders shall have full access to the information in the product database as regards their marketing authorisations.

3. The general public shall have access to information in the product database, without the possibility to change the information therein, as regards the list of the veterinary medicinal products, the summary of product characteristics, package leaflets and, after the deletion of any commercially confidential information by the competent authority, assessment reports.