Paragraph 41 Application for a marketing authorisation where one already exists in another member StateI1

If a veterinary medicinal product has already received a marketing authorisation in another member State at the time of application, and the holder of the marketing authorisation applies for a marketing authorisation in the United Kingdom, the following procedure (“the mutual recognition procedure”) applies.

The applicant must submit to the Secretary of State a dossier identical to the one submitted to the competent authority of the member State in which the veterinary medicinal product has been authorised (“the reference member State”).

If there is a marketing authorisation current in more than one member State the applicant must identify which member State is acting as the reference member State.

If the applicant is applying in more than one member State he must supply the Secretary of State with a list of all the States in which he is applying.

The Secretary of State shall obtain an assessment report from the reference member State and, if the application is made under paragraph 7 (bibliographic applications) or paragraph 10 (applications for pharmacologically equivalent products), ask for the report to include an explanation of any extension of the protection period generated under paragraph 11 or 12.

Within 90 days after receipt of the assessment report, the Secretary of State must, subject to the following provisions, either—

He may only refuse an application on the grounds of serious risk to human or animal health or the environment.

If he approves the assessment report, the summary of product characteristics, the labelling and the package leaflet he shall ensure that he is in a position to decide whether or not to grant a marketing authorisation within 30 days of approving them.

If the Secretary of State is notified by the reference member State that—

the Secretary of State shall within 30 days comply with the decision of the coordination group or, if the coordination group refers the matter to the Agency, the decision of the Commission.

The Secretary of State may grant the marketing authorisation even though not all member States have agreed to grant it, but shall revoke or vary the authorisation if this is necessary to comply with the decision of the Commission when it is received.