S.L. 437.47 · Veterinary Medicinal Products (S.L. 437.47)
S.L. 437.47 Art. 42Variation of a manufacturing and import Authorisation.
TITLE IV
(1)When the holder of the Authorisation requests a change in the particulars specified in regulation 4(a) and 4(b), he shall apply in writing to the Veterinary Services.
The process of verification of such information shall not exceed thirty (30) days. However, in exceptional cases, this period of time may be extended to ninety (90) days.
(2) The veterinary services may upon such an application made by the holder of Authorisation in request thereof, vary the condition of the licence if it is satisfied that such variation will not adversely affect standard of good practice in manufacture as may be prescribed.
(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 manufacturing 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