Regulation 2309 93 pdf file

Table of contents european medical device regulation 2017745. T h i s p u b l i c a t i o n i s a m a j o r revision. The regulations will enter into force on may 25th 2017, marking the start of the transition period for manufacturers selling medical devices into europe. Commission regulation eec no 245493 of 2 july 1993 laying. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents.

Regulation 6184 standards for licensing community residential care facilities disclaimer dhec provides this copy of the regulation for the convenience of the public and makes every effort to ensure its accuracy. If, again, this signifies a policy decision on the part of the commission, all holders of central marketing authorisations, whether these are for veterinary products or for human products, should be concerned about the period of. B council directive 9342eec of 14 june 1993 concerning. New approach to clinical trials and drug registration ncbi. B regulation ec no 7262004 of the european parliament and. Article 2 scope this regulation shall not apply to. Council regulation amending regulation eec no 2309 93 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 common guidelines consultation deadline. Council of the european communities directive 9341eec of 14 june 1993 repealed directive 8722eec on the approximation of national measures relating to the marketing of hightechnology medicinal products, as this directive had been superseded by council regulation eec no 2309 93 of 22 july 1993 laying down community procedures for the. Mdr documentation submissions revision 1, september 2018 page 7 of 29 text recognition and bookmarks. Regulation eec no 230993 council regulation eec no 230993 of 22 july 1993 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a european agency for the evaluation of medicinal products oj no l 214 of 24. Extending the commencement date of the proviso clause after subregulation 7 f of regulation 35 of the national road traffic regulations, 2000. Directive 9339eec of 14 june 1993 amending directives 6565eec.

Silvio garattini, director and vittorio bertele, head of regulatory policies laboratory. Commission regulation eec no 2454 93 of 2 july 1993 laying down provisions for the implementation of council regulation eec no 2992 establishing the community customs code the commission of the european communities, having regard to the treaty establishing the european economic community. Colorado department of public health and environment water. Thank you for using the download pdf file feature, to. The final rule reflects both substantive and nonsubstantive amendments in response to public comments and to correct errors and improve clarity, but the general approach of the nprm is retained. Mainstem of fountain creek, including all tributaries and wetlands, from the source to a point immediately above the confluence with monument creek, except for specific listings in segment 1b.

The regulations most recent final publication in the south carolina state register presents. B regulation ec no 7262004 of the european parliament. This regulation also applies for the examination of applications of variations to the terms of a plasma master file and of a vaccine antigen master file, as defined in annex i of directive 200183ec. Annex to council regulation no eec 2309 93 of 22 july 1993, as amended. The department of health and human services grants policy statement hhs gps is intended to make available in a single document the general terms and conditions of hhs discretionary grant and cooperative agreement awards. The information presented is current as of this publications print date. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and 93 42eec text with eea relevance the european parliament and the council of the european union. Regulation ec no 12232009 of the european parliament and of the council 2. T h i s r e g u l a t i o n p r e s c r i b e s policies governing the army military human resource records management program per dodi 36. Council regulation eec no 230993 of 22 july 1993 laying down community procedures for the authorization and supervision of medicinal. However, this is an unofficial version of the regulation. This regulation shall be binding in its entirety and directly applicable in all member states. Thank you for using the download pdf file feature, to download a correct pdf file, please follow the steps.

The new european medical devices regulation was published in the official journal of the european union on 5th may 2017. Chapter3 marketingauthorisationprocedure article8 evaluationprocedure 1. These general terms and conditions are common across all hhs operating divisions opdivs. The next group of slides will take you through the web upload process. The rapporteur and corapporteur appointed by the chmp were. An analysis of marketing authorisation applications via the mutual. And when you want to do more, subscribe to acrobat pro. This regulation lays down the procedure for the examination of applications for the transfer of a marketing authorization granted in accordance with regulation ec no 2309 93, except for the situations covered by point 3 of annex i to regulation ec no 54295. Regulations, 2000 under the national road traffic act, 1996 act no. Encapsulation means the treatment of acbm with a material that surrounds or embeds asbestos fibers in an adhesive matrix to prevent the release of fi. Council regulation eec no 230993 of 22 july 1993 laying down. Commission regulation ec no 10852003 of 3 june 2003.

New mexico regulation and licensing department construction. Then you can edit, export, and send pdfs for signatures. Regulation eec no 230993 of 22 july 1993 and council. Council regulation amending regulation eec no 230993. Council regulation eec no 230993 of 22 july 1993 laying down community procedures for the authorization and supervision of medicinal products for. After conversion, you can see that there are following files listed in output folder. Do not combine documents belonging to different soldiers within a single pdf file, if you do it must be flattened scanned or flattened with approved software. Only with adobe acrobat reader you can view, sign, collect and track feedback, and share pdfs for free. 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 regulation eec no 2309 93 of 22 july 1993 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a european agency for the evaluation of medicinal products official journal l 214, 24081993 p.

Having regard to council regulation eec no 230993 of 22 july 1993 laying down community procedures for the authorisation and. New approach to clinical trials and drug registration. The product was not licensed in any country at the time of submission of the application. Article 8 this regulation shall enter into force on the third day following its publication in the official journal of the european communities. Regulation 619 water pollution control permits disclaimer dhec provides this copy of the regulation for the convenience of the public and makes every effort to ensure its accuracy.

This document is meant purely as a documentation tool and the. Asbestos debris originating from the acbm in question may also indicate damage. For medicinal products falling within the scope of part a of the annex to council regulation eec no 230993 of 22 july 1993 laying down. Regulation ec no 342008 of the european parliament and of the council of 16 december 2008 on flavourings and certain food ingredients with flavouring. Whereas article 58 of council regulation eec no 230993 of 22 july 1993 laying down. The proposed part 93 was published for public comment on april 16, 2004. Presentation and distribution of medicinal products after the new. And when you want to do more, subscribe to acrobat pro dc. Army military human resource records management army regulation 6008104 effective 7 may 2014 h i s t o r y. B regulation ec no 342008 of the european parliament and.

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