Paragraph 7 Inspection of premises

The Secretary of State must inspect the premises relating to a manufacturing authorisation on a regular basis to ensure compliance with good manufacturing practice.

Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection established that he is complying with the principles and guidelines on good manufacturing practice in accordance with Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products^f1.

If an inspection is carried out at the request of the European Pharmacopoeia to establish compliance with a monograph, the Secretary of State must issue a certificate of compliance with the monograph, if appropriate.

The Secretary of State must provide details of each certificate of good manufacturing practice that he issues to the Agency for entry into a database.

If the outcome of the inspection is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice, he must provide details to the Agency for entry into the database.