147.B.110 Approval procedure

the trial period and time schedule for the whole authorization procedure,

Which competent authority or authorities are involved in permitting IPPC installations?

The rules governing part-time work and the procedure for granting authorisation are laid down in Annex IVa.";

if an approval process is being carried out by several Member States, the most advanced project shall be used as the reference;

Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(12), provides for an authorisation procedure for placing on the market additives used in feedingstuffs.

whereas furthermore that authorisation procedure includes a control relating specifically to the classification, packaging and labelling of each product before it is placed on the market;

Since many smoke flavourings are already on the market in the Member States, provision should be made to ensure that the transition to a Community authorisation procedure is smooth and does not disturb the existing smoke flavourings market.

With regard to products that have a national type-certificate, or equivalent, and for which the approval process of a change carried out by a Member State is not finalised at the time when the type-certificate is determined in accordance with this Regulation:

An authorisation procedure involving Member States and the Commission has been established for genetically modified foods in Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients(5).

Vaccination against list II diseases in approved zones or in approved farms situated in non-approved zones, in zones or farms which have already begun the approval procedures laid down by Directive 91/67/EEC, and against list I diseases, shall be forbidden.

Vaccination against list II diseases in approved zones, in approved farms situated in non-approved zones or in zones or farms which have already begun the approval procedures laid down by Directive 91/67/EEC and against list I diseases shall be forbidden.

It is therefore necessary to provide for a procedure for the communication of the approval of laboratories in third countries.

Whereas Directive 91/414/EEC and Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(10), in contrast to the provisions applicable to chemical preparations covered by this Directive, provide for an authorisation procedure for each product on the basis of a dossier presented by the applicant and an assessment carried out by the competent authority in each Member State;

In the case of indirect approval, the maintenance programme procedure shall be approved by the competent authority through the continuing airworthiness management exposition.

decisions taken or contracts made by the management body of an issuer which need the approval of another body of the issuer in order to become effective, where the organisation of such an issuer requires the separation between these bodies, provided that a public disclosure of the information before such approval together with the simultaneous announcement that this approval is still pending would jeopardise the correct assessment of the information by the public.

By way of derogation from paragraphs 1 to 4, the Commission, in accordance with the procedure referred to in Article 23(2), may provide for an accelerated or simplified procedure for approval in specific cases, in particular for beef in small retail packages or prime beef cuts in individual packages, labelled in a Member State according to an approved specification and introduced into the territory of another Member State, provided that no information is added to the initial label.

That management is characterised by an approval procedure which requires operators to submit approval applications by 1 April each year.

This Subpart establishes the procedure for the approval of repair design, and establishes the rights and obligations of the applicants for, and holders of, those approvals.

Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a plant protection product, to an administrative authorization procedure as laid down in Article 4 of Directive 91/414/EEC (6), or pursuant to an equivalent provision of national law if it is a plant protection product in respect of which the application for authorization was lodged before Directive 91/414/EEC was implemented by the Member State concerned, may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.

This Subpart establishes the procedure for the approval of design organisations and rules governing the rights and obligations of applicants for, and holders of, such approvals.

Whereas, however, a rapid Community procedure should be provided for settling disputes between Member States as to the justification for the approval of a slaughterhouse or cutting room;

In order to ensure that approved rapid tests maintain the same level of performance after approval a procedure should be laid down for possible modifications to the test or the test protocol.

The procedure laid down in Article 22 must be followed for the approval and subsequent updating of the list of quarantine centres referred to in the first and second indents of paragraph 1 and the first indent of paragraph 2.

The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Implanon.

The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sanohex.

"Applicable" means relevant to any aircraft, component or process specified in the organisation's approval class rating schedule and in any associated capability list.

The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sabumalin.

the act of formal recognition of such compliance with the applicable requirements by the issue of a certificate, licence, approval or other document in the manner required by national laws and procedures;

This Subpart establishes the procedure for demonstrating the conformity with the applicable design data of a product, part and appliance that is intended to be manufactured without a production organisation approval under Subpart G.

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 542/95.

The scope of the referral included all pending Marketing Authorisation applications as well as all Marketing Authorisations for medicinal products containing 150 mg bicalutamide. Further, the referral concerned only

To the extent that for certain aspects the final testing according to section 6.3 is not appropriate, adequate process testing, monitoring and control methods shall be established by the manufacturer with the approval of the notified body.

Germany could not agree to the granting a marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).

The MRP procedure was finalised on Day 221 of the procedure on 09.05.2006 with approval of the proposed indication and inclusion of the liver and kidney imaging studies’ results under Section 5.1.

The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Uman Big 180 IU/ ml, solution for injection.

The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Bleomycin injection, from Pharmachemie BV.

Whereas it is necessary in particular to institute an administrative procedure to enable the marketing authorization decision to be quickly amended in that event, provided that the transfer application submitted is valid and the conditions relating to it have been fulfilled;

where certain production practices so require, the Commission shall determine, pursuant to Article 14 and by 31 December 1991, the existence of special cases and shall lay down specific conditions according to which egg products coming from an approved establishment may be treated in another approved establishment, on the unterstanding that the following general conditions are complied with:

Whereas, if the checking system is to function smoothly there must be an approval procedure and border inspection posts must be inspected and there should by exchanges of officials empowered to carry out checks on live animals coming from third countries;

For the purposes of this Regulation, 'transfer of a marketing authorization` means the procedure of changing the addressee (hereinafter referred to as 'the holder`) of the marketing authorization decision adopted pursuant to Article 10 (1) and (2) or Article 32 (1) and (2) of Council Regulation (EEC) No 2309/93, the new holder not being the previous holder.

In the light of practical experience in the application of Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State(3), as amended by Regulation (EC) No 1146/98(4), it is appropriate to simplify the procedure for varying the terms of a marketing authorisation.

The Management Board, having received the Commission's approval and the opinion of the Court of Auditors, shall adopt the Authority's financial regulation which specifies in particular the procedure for drawing up and implementing the Authority's budget, in accordance with Article 142 of the Financial Regulation of 21 December 1977 applicable to the general budget of the European Communities(26) and with the legislative requirements concerning investigations conducted by the European Anti-Fraud Office.

During their April 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral should not prevent the granting of a Marketing Authorisation for Oracea and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.

Whereas Council Directive 93/39/EEC of 14 June 1993 amending Directive 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products (9) has provided that in the event of a disagreement between Member States about the quality, safety or efficacy of a medicinal product which is the subject of the decentralized Community authorization procedure, the matter should be resolved by a binding Community decision following a scientific evaluation of the issues involved within a European medicinal product evaluation agency;

The procedure referred to in Article 8(2) shall apply in respect of the approval, on the basis of compliance with the priorities established in Article 4 and the principles laid down in Article 5, of the section of the IDA work programme concerning the implementation of this Decision, which the Commission shall draw up at yearly intervals and which may be reviewed during the year of reference. The IDA work programme shall include: - a breakdown of past expenditure by project for the previous year(s), - an estimate of the future costs to be funded by the Community and the Member States, and - a short statement on the results/services developed from this past expenditure.