Examples of using Concerning the authorisation in English and their translations into Bulgarian
{-}
-
Medicine
-
Official
-
Colloquial
-
Ecclesiastic
-
Ecclesiastic
-
Computer
Draft Commission Implementing Regulation concerning the authorisation of L-threonine as a feed additive for all animal species.
Femara was included in the list of products for Summary of Product Characteristics(SmPC) harmonisation,due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product.
This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.
Tazocin was included in the list of products for Summary of Product Characteristics(SPC) harmonisation,due to the divergent national decisions taken by Member States concerning the authorisation of the product.
R 0277: Commission Regulation(EC) No 277/2004 of 17 February 2004 concerning the authorisation without a time limit of an additive in feedingstuffs OJ L 47, 18.2.2004, p.
Commission Regulation(EC) No 209/2008 of 6 March 2008 concerning the authorisation of a new use of Saccharomyces cerevisiae(Biosaf Sc 47) as a feed additive(Text with EEA relevance).
(b)“Competent authority” is any central, regional or local government and authority or non-governmental body in the exercise of powers delegated by central or regional or local governments or authorities,which takes a decision concerning the authorisation to supply a service, or concerning the authorisation to establish an enterprise in order to perform an economic activity.
R 1289: Commission Regulation(EC) No 1289/2004 of 14 July 2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances OJ L 243, 15.7.2004, p.
Competent authorities' means any central, regional or local government or authority, or any non-governmental body exercising powers delegated by central or regional or local governments or authorities,which takes a decision concerning the authorisation to supply a service, including through establishment, or concerning the authorisation to establish an economic activity other than services;
R 1356: Commission Regulation(EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive"Elancoban" in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances OJ L 251, 27.7.2004, p.
(e)"competent authority" means any central, regional or local government and authority or non-governmental body in the exercise of powers delegated by central or regional or local governments orauthorities which takes a decision concerning the authorisation to supply a service, including through establishment, or concerning the authorisation to establish in an economic activity other than services.
R 1464: Commission Regulation(EC) No 1464/2004 of 17 August 2004 concerning the authorisation for 10 years of the additive"Monteban" in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances OJ L 270, 18.8.2004, p.
And, after consulting with the holder of the permit for use issued a reasoned recommendation concerning the authorisation for the use of the medicinal product and send it to.
(2) Commission Regulation(EC) No 1289/2004 of 14 July 2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances[2] is to be incorporated into the Agreement.
(2) Commission Regulation(EC) No 277/2004 of 17 February 2004 concerning the authorisation without a time limit of an additive in feedingstuffs[2] is to be incorporated into the Agreement.
R 1455: Commission Regulation(EC) No 1455/2004 of 16 August 2004 concerning the authorisation for 10 years of the additive"Avatec 15%" in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances OJ L 269, 17.8.2004, p.
R 1800: Commission Regulation(EC) No 1800/2004 of 15 October 2004 concerning the authorisation for 10 years of the additive Cycostat 66G in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances(OJ L 317, 16.10.2004, p. 37).".
(3) Commission Regulation(EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive"Elancoban" in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances[3] is to be incorporated into the Agreement.
(2) Commission Regulation(EC) No 1800/2004 of 15 October 2004 concerning the authorisation for 10 years of the additive Cycostat 66G in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances[2] is to be incorporated into the Agreement.
Due to the divergent national decisions taken by Member States concerning the authorisation of Doxyfar 50% and associated names, the issue was referred to CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics(SPC) across the European Union.
Due to the divergent national decisions taken by Member States concerning the authorisation of Zyrtec, a number of divergences exist in the product information and a referral was therefore triggered by the European Commission Article 30 of Directive 2001/ 83/ EC as amended in order to harmonise the divergent Product Information texts across the EU.
Due to the divergent national decisions taken by Member States(MS) concerning the authorisation of Ikorel and its associated names and Dancor and its associated names, these products were included in the list of products for Summary of Product Characteristics(SmPC) harmonisation, requested by the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman(CMDh).
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product(and its associated names),the European Commission(EC) notified the European Medicines Agency's Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve the divergences amongst the nationally approved SmPCs and thus to harmonise its divergent SmPCs across the EU.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product,the European Commission notified the CHMP/European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC as amended, in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Due to the divergent national decisions taken by Member States concerning the authorisation of Rocephin and associated names,the European Commission notified the EMA of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product informations for the above-mentioned products and thus to harmonise them across the EU.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product(and its associated names),the European Commission notified the CHMP/EMEA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product(and its associated names),the European Commission notified the CHMP/ EMEA Secretariat of an official referral under Article 30 of Directive 2001/ 83/ EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Due to the divergent national decisions taken by Member States concerning the authorisation of Durogesic and associated names,the European Commission(EC) notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the authorised summary of product characteristics(SmPCs) for the above-mentioned product, and thus to harmonise the SmPCs across the EU.