Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 95 U.K. Importers, manufacturers and distributors of active substances established in the Union

1. Importers, manufacturers and distributors of active substances used as starting materials in veterinary medicinal products, that are established in the Union, shall register their activity with the competent authority of the Member State in which they are established and shall comply with good manufacturing practice or good distribution practice, as applicable.

2. The registration form for registering the activity with the competent authority shall include at least the following information:

(a) name or company name and permanent address or registered place of business;

(b) the active substances which are to be imported, manufactured or distributed;

(c) particulars regarding the premises and the technical equipment.

3. The importers, manufacturers and distributors of active substances referred to in paragraph 1 shall submit the registration form to the competent authority at least 60 days prior to the intended start of their activity. The importers, manufacturers and distributors of active substances in operation before 28 January 2022 shall submit the registration form to the competent authority by 29 March 2022.

4. The competent authority may, based on a risk assessment, decide to carry out an inspection. If the competent authority notifies within 60 days of receipt of the registration form that an inspection will be carried out, the activity shall not begin before the competent authority has notified that the activity may start. In such a case, the competent authority shall carry out the inspection and communicate to the importers, manufacturers and distributors of active substances referred to in paragraph 1 the results of the inspection within 60 days of the notification of its intention to carry out the inspection. If within 60 days of receipt of the registration form the competent authority has not notified that an inspection will be carried out, the activity may start.

5. The importers, manufacturers and distributors of active substances referred to in paragraph 1 shall communicate annually to the competent authority the changes which have taken place as regards the information provided in the registration form. Any changes that may have an impact on the quality or safety of the active substances that are manufactured, imported or distributed shall be notified immediately.

6. Competent authorities shall enter the information provided in accordance with paragraph 2 of this Article and with Article 132 in the manufacturing and wholesale distribution database referred to in Article 91.

7. This Article shall be without prejudice to Article 94.

8. The Commission shall, by means of implementing acts, adopt measures on good distribution practice for active substances used as starting materials in veterinary medicinal products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).