Примери за използване на Authorisation holders на Английски и техните преводи на Български
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Colloquial
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Medicine
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Ecclesiastic
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Ecclesiastic
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Authorisation holders must comply with the conditions of the decision.
Written explanations were provided by the applicants/marketing authorisation holders on 21 April 2009 and 16 September 2009.
If the authorisation holders do not succeed in this, they can submit a review report.
Written explanations were provided by the applicants/marketing authorisation holders on 15 July 2009 and 13 January 2010.
For that purpose, marketing authorisation holders shall update accordingly the documentation mentioned in point(b) of Article 7(1).
Хората също превеждат
Written explanations were provided by the applicants and marketing authorisation holders on 16 May 2014 and 4 September 2014.
For that purpose, marketing authorisation holders shall update accordingly the documentation mentioned in Article 7(1)(b).
No residue depletion data in sheep and goat milk were provided by the applicants/marketing authorisation holders.
Written explanations were provided by the applicants and marketing authorisation holders on 14 November 2011 and on 30 November 2012.
No other residue depletion data in sheep meat and offal were provided by the applicants/marketing authorisation holders.
Where a transfer is carried out between two authorisation holders established in the same Member States, this shall be done in accordance with national rules.
No written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders.
If the update of the AoA shows that there is a suitable alternative, authorisation holders have to submit a substitution plan.
Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems.
That period may be extended by the Committee for a further period of up to 60 days,taking into account the views of the marketing authorisation holders concerned.
Downstream users should also be in contact with the authorisation holders and suppliers and provide them with information for a possible review report.
Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration,marketing authorisation holders in the Member States.
Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, withdrawal period,marketing authorisation holders in the Member States.
During this period, authorisation holders have to continue looking for a suitable alternative substance or technology that would make the use of the substance of very high concern(SVHC) unnecessary.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, indications,marketing authorisation holders in the Member States.
(d) inspect the premises, records and documents of marketing authorisation holders or any firms performing the activities described in Title VII, and in particular Articles 74 and 75 thereof, on behalf of a marketing authorisation holder. .
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration,marketing authorisation holders in the Member States.
Analysis of alternatives(AoA)- Authorisation holders must submit an update of the AoA, including information about any relevant research and development activity, possible new alternatives and progress made towards substitution with safer alternatives.
List of the names, pharmaceutical forms, active substance, strengths of the veterinary medicinal products, animal species,marketing authorisation holders in the Member States.
Veterinary medicinal products as referred to in paragraph 1 which were authorised when this Regulation enters into force shall be taken off the market by the authorisation holders.
List of the names, pharmaceutical forms, strengths of the medicinal products,routes of administration, marketing authorisation holders in the member states for Combined hormonal contraceptives.
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration,marketing authorisation holders in the Member States.
Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration,marketing authorisation holders in the Member States.
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration,marketing authorisation holders in the Member States.