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S.L. 437.47 · Veterinary Medicinal Products (S.L. 437.47)

S.L. 437.47 Art. 41Time taken for the procedure to grant the authorisation.

TITLE IV

In KraftAmtlicher Text

(1)(a)The Veterinary Services shall issue the Authorisation after verifying the contents of the application but in any case not later than ninety (90) days from receipt of the application.

(b) This time period shall be suspended when the Veterinary Services requests additional information from the applicant.

(c) The Veterinary Services shall, before determining an application, inspect the premises indicated in the application and shall not issue an Authorisation until it is satisfied that such premises conform with the requirements established by the provisions of these regulations;

(d) The Veterinary Services may grant a conditional licence subject to the carrying out of certain obligations imposed on the applicant.

(2) The Authorisation shall apply only to the premises, veterinary medicinal products and pharmaceutical forms specified in the application.

(3) Where the Veterinary Services considers that circumstances may exist which would render necessary the consideration of whether the Authorisation should be varied, suspended or revoked, the Veterinary Services may serve on the holder of a manufacturer's Authorisation a notice requiring him, within such time as may be specified in the notice, to furnish it with any information specified in the notice.

Änderungsgeschichte
  • Amended by L.N. 179 of 2021