Directive 6565eec council directive 6565eec of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products oj l no 22 of 9. Comments of the united states on council directive 80181eec. The united states commends the european commission for reconsidering the deadline on the prohibition on supplementary indications, and applauds the commission for conducting this. Council directive 9265eec of july 1992 laying down. Having regard to council directive 91414eec of 15 july 1991 concerning the placing of plant protection products on the market, and in particular article 18 2 thereof, whereas annexes ii and iii to directive 91414eec lay down the requirements for the dossier to be submitted by applicants respec. May 08, 2019 the balai directive article 4 of council directive 92 65 eec sets out the conditions for the import and export of various species of animals within the eu which are not covered by other. B council directive 9342eec of 14 june 1993 concerning.
References to directive 200439ec or to directive 9322 eec shall be construed as references to directive 2014 65 eu or to regulation eu no 6002014 and shall be read in accordance with the correlation table set out in annex iv of directive 2014 65 eu. Unless your products are specifically listed as one of the. This directive constitutes a specific directive within the meaning of article 2 2 of council directive 89336 eec of 3. Council directive 92 65 eec of july 1992 laying down animal health requirements governing trade in and imports into the community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific community rules referred to in annex a i to directive 90425 eec oj l 268, 14. M1 council directive 74290 eec of 28 may 1974 l 159 61 15.
What manufacturers need to know and do updated 23 june 2014 rohs2 directive officially in effect july 2011 the recast rohs directive was published in the official journal by the european commission, inwhich now makes it a legal document you need to comply with. Council directive 92 65 eec of july 1992 laying down animal health requirements governing trade in and imports into the community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific community rules referred to in annex a i to directive 90425ee. This includes the classification of the fluid contained in the pressure equipment as dangerous or not, according to council directive 67548 eec 1. Council directive 9342eec of 14 june 1993 concerning medical devices the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof. Council directive 65 65 eec of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. The instrument is a delegated directive, as provided for by directive 2011 65 eu, and in. Import of animals under the balai council directive 9265eec. Council directive 9342eec concerning medical devices. For any questions, comments, or feedback regarding the epeat registry, please contact us.
Council directive 9322 eec of 10 may 1993 on investment services in. B council directive 9265eec of july 1992 laying down. Istituto zooprofilattico sperimentale del piemonte, liguria e valle daostaizsplva. In addition, manufacture shall mean any holder of the authorisation referred to in article 16 of directive 75319 eec. Directive 6565eec1 was the first european pharmaceutical directive. The scf report covers all of the vitamins and minerals listed in directive 200115 eec foods for particular nutritional use, directive 200246 eec food supplements, and in the draft proposal on the addition of vitamins and minerals. Council directive 6565eec of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal. Market financial instruments directive ii mifid ii level 1. Certificate for the approval in accordance with council directive 92 65 eec of an equine semen collection centre. Council directive 9339 eec of 14 june 1993 amending directives 65 65 eec, 75318 eec and 75319 eec in respect of medicinal products displaylogo publications office of the european union. Certificate for the approval in accordance with council.
Proposal for a council directive amending directives 6565eec. Proposal for a council directive amending directives 6565. Directive 201165eu of the european parliament and of the. Directive of the european parliament and of the council 200441ec repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending council directives 89662 eec and 92118 eec and council decision 95408ec. Wikiproject european union rated stubclass, lowimportance this article is within the scope of wikiproject european union, a collaborative effort to improve the coverage of the european union on. This number is a sevendigit system of the type xxxxxxx which starts at 400. The directive was a reaction to the thalidomide tragedy in the early 1960s, when thousands of babies were born with deformities as a result of their mothers taking thalidomide during pregnancy.
Ce marking ce mark, eu commision communication in the framework of the implementation of eu council directive 89336eec. Recommendations for the application of annex c to council. Modifications of commission directive 956eec of june. B council directive 9342eec of 14 june 1993 concerning medical devices the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof, having regard to the proposal from the commission 1, in cooperation with the european parliament 2. Council directive of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products 65 65 eec the council of the european economic community, having regard to the treaty establishing the european economic community, and in particular article 100 thereof. On 1 june 2015 directive 67548 eec is to be repealed and. The objective of the proposed act is to ensure legal certainty and sustainable market. Please find the latest consolidated ivdd 9879ec below. Proposal for a council directive amending directives 65 65 eec and 75319 eec on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. The amendment of 15 july 2002 to the council directive 92 65 eec laying down animal health requirements governing trade in and imports into the community of. If you would like to participate, please visit the project page, where you can join the discussion and see a list of open tasks. For dangerous substances notified under the provisions of this directive, the number of the substance in the european list of notified substance elincs is included.
Directive 2014 65 eu of the european parliament and of the council of 15 may 2014 on markets in financial instruments and amending directive 200292ec and directive 201161eu. Council directive 9265eec of july 1992 laying down animal health requirements governing trade in and imports into the community of animals. Article 22 of directive 9232 eec and assigning the qualifying risk phrase or phrases. Council directive 92 65 eec of july 1992as amended lays down the animal health rules for intra eu trade in animals, semen, ova and embryos not subject to animal health requirements laid down in other specific community rules. Beginning with council directive 6565eec,6 which was introduced in the wake of the thalidomide disaster, the theneuropean economic community began developing structured legislation. Application of an establishment for approval under article.
Health certificate for trade in animals from holdings. Council directive 9465ec laying down the requirements for. Directive 201465eu of the european parliament and of the. Council directive 6566eec of 26 january 1965 laying down. The ivd directive was amended and corrected over time. Medicinal products in the european union page 6 of 25 1. Experience of the application of directive 9265eec balai directive in european zoos and how to set up a suitable health surveillance program jacques kaandorp torino 24 th november 2017 workshop on the enforcement of directive 9265cee in italian zoos.
The directive was a reaction citation needed to the thalidomide tragedy in the early 1960s, when. Council directive 9322 eec of 10 may 1993 on investment services in the securities field oj l 141, 11. Directive 85611 eec has largely contributed to the devel. Chapter i general provisions article 1 this directive lays down the principles and.
B council directive 92 65 eec of july 1992 laying down animal health requirements governing trade in and imports into the community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific community rules referred to in annex a i to directive 90425 eec. Directive 65 65 eec, manufactured or imported in accordance with the provisions of directives 75 319 eec and 956 eec, and on patients with the. Council directive 6565eec of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary. Council directive 65 65 eec of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, council directive 75318 eec of 20 may 1975 on the approximation of the laws of member states relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal. Directive 65 65 eec1 was the first european pharmaceutical directive. The delegated directive grants an exemption from the restrictions in article 41, to be listed in annex iii of directive 2011 65 eu, for the use of cadmium and lead in specific applications. Council directive 92 65 eec applies to all other commercially traded animals, semen, ova and embryos that are not covered by other legislation as listed below. Annex 1 provides a comparison between the figures proposed by the scf and those in. Council directive 92 65 eec of july 1992 laying down animal health requirements governing trade in and imports into the community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific community rules referred to in annex a i to directive 90425 eec. Directive 90496eec on nutrition labelling for foodstuffs. Council directive 90429 eec for imports into the union of porcine semen. Directive 200965ec of the european parliament and of the.
The directive was a reaction citation needed to the thalidomide tragedy in the early 1960s, when thousands of babies were born with deformities as a result of their mothers taking the drug during pregnancy. Council directive 80181 eec on the approximation of the laws of the member states relating to the units of measurement commonly known as the metriconly directive. Council directive 65 65 eec of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products official journal 022, 09021965 p. The balai directive article 4 of council directive 92 65 eec sets out the conditions for the import and export of various species of animals within the eu which are not covered by other. Directive 9322eec investment services directive better. Council directive 92 65 balai as amended by council regulation ec no 12822002 of 15 july 2002 oj l 1873 in approved zoos introduction. The proposed instrument is a delegated directive, as provided for by directive 2011 65 eu, and in particular article 51a thereof. Experience of the application of directive 9265eec balai. Directive 9462ec on packaging and packaging waste karolina fras dg environment sustainable production and consumption unit.
Council directive 65 66 eec of 26 january 1965 laying down specific criteria of purity for preservatives authorised for use in. Article 2 for the purposes of this directive, the definition of medi cinal products set out in article 1 2 of council directive 65 6s eec f, and the definition of veterinary medicinal products set out in article 1 2 of directive 8 1851 eec, shall apply. B council directive 9342eec of 14 june 1993 concerning medical devices the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof. Pet animals dogs, cats, ferrets, invertebrates except bees and crustaceans, ornamental aquatic animals. Directive 2011 65 eu for the use of lead in specific applications. The classification has consequences not only for labelling but also for other legislation and regulatory measures on dangerous substances. This item of legislation is only available to download and view as pdf.
Certificate for the approval in accordance with council directive 92 65 eec of an equine semen collection. Council directive 9339eec of 14 june 1993 amending. Has notification been completed in accordance with directive 65. View pdf council directive 6565eec of 26 january 1965 on the approximation of.
As well as extending the restrictions to new categories of equipment, the regulations. Import of animals under the balai council directive 92. Council directive 6565eec of 26 january 1965 on the. Commission delegated directive eu of xxx lead in bearing. For the purposes of this directive, the definition of medicinal products set out in article 1 2 of council directive 65 65 eec 3, shall apply. The directive aimed at citation needed harmonising standards for the approval of medicines within the then european economic community. Proposal for a council directive amending directives 6565eec and 75319 eec on the approximation of. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission.
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