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10 primjeri rečenice
- The competent authority or the Commission shall suspend or withdraw the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation where the withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a public health hazard.
- When applying for variations to the terms of several marketing authorisations held by the same marketing authorisation holder and granted by different competent authorities and or the Commission, the marketing authorisation holder shall submit an application to all competent authorities concerned and the Agency.
- A marketing authorisation holder may implement a variation requiring assessment only after a competent authority or the Commission has amended the decision granting the marketing authorisation in accordance with that variation and the holder has been notified thereof.
- The competent authority or the Commission may at any time grant a marketing authorisation valid for an unlimited period of time, provided that the marketing authorisation holder submits the missing comprehensive safety and efficacy data referred to in Article 22 1 .
- The competent authority or the Commission may suspend or withdraw the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation in case of any of the following
- a the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder
- Where requested by a competent authority or the Agency, a marketing authorisation holder shall supply without delay any information related to a variation to the terms of a marketing authorisation.
- This may be initiated voluntarily by the marketing authorisation holder or may be carried out as a condition imposed by the competent authority following authorisation for pharmaceutical products.
- the veterinary medicinal products with name, active substance, strength, added amount, marketing authorisation holder and marketing authorisation number, preceded by the heading medication
- The marketing authorisation holder shall, based on pharmacovigilance data and where necessary, submit changes to the terms of a marketing authorisation in accordance with Article 61.
Rječnik tekstova kao nositelj odobrenja na engleskom
sinonimi nositelj odobrenja na engleskom
carrier bearer holder seeded Awards approval clearance authorization say-so consent