Council Regulation

Community m 2000 under Council Regulation (ECj No. 3093/94 on substances that deplete the ozone layer... [Pg.567]

Commission Regulation (EC) No. 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No. 2309/93... [Pg.12]

Council Regulation (EEC) No. 2377/90 of 26 June 1990 laying down a Commrmity procedure for the establishment of maximum residue limits for veterinary medicinal products in foodstuffs of animal origin. [Pg.12]

Council Regulation (EEC) No. 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products... [Pg.12]

The Community procedure for establishing MRLs of veterinary medicines in foodstuffs of animal origin is set down in Council Regulation (EEC) No. 2377/90 as amended by Council Regulation (EC) No. 1308/1999. The regulations are supported by detailed guidance contained in The Rules Governing Medicinal Products in the European Union, Volume 8 - Maximum Residue Limits. [Pg.138]

APPLICATION FOR THE ESTABLISHMENT OF MRL(s) FOR AN ACTIVE SUBSTANCE TO BE USED IN VETERINARY MEDICINAL PRODUCTS IN ACCORDANCE WITH COUNCIL REGULATION (EEC)... [Pg.139]

Priority Lists, Risk Assessment process and tracking system in relation to Council Regulation (EEC) 793/93 also known as Existing Substances Regulation (ESR). [Pg.314]

The EEA was set up as a legally independent community body under council regulation (EEC) 1210/90. The EEA s core task is to provide decisionmakers with the information needed for making sound and effective policies to protect the environment and support sustainable development. [Pg.30]

Council Regulation (EU) No 333/2011 of 31 March 2011 establishing criteria determining when certain types of scrap metal cease to be waste under Directive 2008/98/EC of the European Parliament and of the Council. Official Journal of the European Union L 92/2, 8.4.2011. http // eur-lex.europa.eu/LexUriServ/LexUriServ.do uri=OJ L 2011 094 0002 0011 EN PDF... [Pg.152]

CONSLEG 1991R2092 - 01/05/2004 Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. [Pg.140]

The current situation with regard to risk assessment in the use of several different types of flame retardant is reviewed with respect to EEC council regulation No.793/93. Included in the review are chlorinated, brominated phosphorous and antimony trioxide types of retardant. 0 refs. [Pg.34]

An overview is provided of ongoing risk assessments on halogenated phosphate ester flame retardants in Europe. On the basis of the so-called second and fourth Priority lists on Existing Chemicals (Council Regulation No793/93) three chlorinated phosphate ester flame retardants are selected. The selection is based on their hazard profile, volume and use pattern. The three substances involved are TCPP, TDCP and TCEP (Antiblaze V6 from Albemarle is also involved but, due to confidentiality, is not discussed. An outline is provided from a European point of view on topics such as methodology of risk analyses, data-gaps and worst case approach, industry involvement, downstream participation and possible impact of final report on industry. 2 refs. [Pg.35]

Risk assessment, existing substances Council Regulation (EEC) 793/93 EU... [Pg.587]

European Council Regulation AP(96)5 Surface coatings intended to come into... [Pg.588]

Council Regulation EEC/2309/93 together with Directive 75/319/EEC require member states to establish a national pharmacovigilance system to collect and evaluate information on adverse reactions to medicinal products and to take appropriate action. [Pg.215]

EC (1992). Council Regulation (EEC) No 2078/92 on agricultural production methods compatible with requirements of the protection of the environment and the maintenance of the countryside. Official Journal of the European Communities L215 (30/7/92) 85-90. [Pg.105]

EFSA was legally established by a European Parliament and Council Regulation adopted in 2002 following a series of food scares in the 1990s including the Bovine Spongiform Encephalopathy and dioxins scandals, which undermined consumer confidence in the safety of the food chain (EFSA 2007). [Pg.366]

Every company is required by European law to have a nominated person responsible for phar-macovigilance (Council Regulation EEC 2309/93 Article 23). They are not required to be a physician but must have access to one. [Pg.338]

Regulation (EEC) No 2309/93. Council Regulation (EEC) No 2309/9 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. [Pg.444]

Applicants are free to solicit advice from individual Member States and according to various surveys conducted by the European Federation of Pharmaceutical Industries and Associations, they often do. Apart from the FDA, these surveys reveal, the EU Member States most often consulted are Germany, France, Sweden and the United Kingdom. Flowever, it is often important to secure a pan-European advice. Article 51 of Council Regulation EEC/2309/93 requires the EMEA to provide the Member States and the institutions of the Commimity with the best possible scientific advice on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human... [Pg.509]

Preparation of reports referred to in Council Directive 75/319/EEC for competent authorities and for centrally authorised products, for competent authorities and EMEA, reports referred to in Council Regulation EEC/2309/93 ... [Pg.526]

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