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1. The Agency shall establish and maintain a Union database on manufacturing, import and wholesale distribution (‘manufacturing and wholesale distribution database’).

2. The manufacturing and wholesale distribution database shall include information regarding the grant, suspension or revocation by competent authorities of any manufacturing authorisations, wholesale distribution authorisations, certificates of good manufacturing practice, and registrations of manufacturers, importers and distributors of active substances.

3. Competent authorities shall record in the manufacturing and wholesale distribution database information on manufacturing and wholesale distribution authorisations and certificates granted in accordance with Articles 90, 94 and 100 together with information on importers, manufacturers and distributors of active substances registered in accordance with Article 95.

4. The Agency shall, in collaboration with Member States and the Commission, draw up functional specifications, including the format for electronic submissions of data, for the manufacturing and wholesale distribution database.

5. The Agency shall ensure that information reported to the manufacturing and wholesale distribution database is collated and made accessible and that the information is shared.

6. The competent authorities shall have full access to the manufacturing and wholesale distribution database.

7. The general public shall have access to information in the manufacturing and wholesale distribution database, without the possibility to change that information therein.