Commission Decision of 10 March 2003 concerning the non-inclusion of parathion-methyl in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance

In order to consider lifting the suspension of the marketing authorisations residue depletion data on later time points allowing to establish withdrawal periods for both cattle and pigs meat and offal would be necessary.

These data resulted in the worldwide withdrawal of rofecoxib (Vioxx) from the market on 30 September 2004 by the Marketing Authorisation Holder and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL

Commission Decision of 30 January 2004 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances

Council Regulation (EC) No 1756/2002 of 23 September 2002 amending Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of an additive and amending Commission Regulation (EC) No 2430/1999

Commission Regulation (EC) No 2205/2001 of 14 November 2001 amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of certain additives(5) is to be incorporated into the Agreement.

COMMISSION REGULATION (EC) No 45/1999 of 11 January 1999 amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of certain additives belonging to the group of coccidiostats and other medicinal substances

Member States or the Commission or the applicant or marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Articles 36, 37 and 38 before a decision is reached on a request for a marketing authorisation or on the suspension or withdrawal of an authorisation, or on any other variations to the terms of a marketing authorisation which appear necessary, so as to take account in particular of the information collected in accordance with Title VII.

The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could affect the protection of public health, is communicated to each other with the appropriate degree of urgency.

The Parties will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could affect the protection of public health, are communicated to each other with the appropriate degree of urgency.

By Commission Decision 2001/520/EC of 9 July 2001 concerning the non-inclusion of parathion in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance(8) and Commission Decision 2003/166/EC of 10 March 2003 concerning the non-inclusion of methyl parathion in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance(9), those substances have now been excluded from Annex I to Directive 91/414/EEC and authorisations for plant protection products containing them have been withdrawn.

In order to ensure a harmonised conclusion on the establishment of the withdrawal periods, it is highly recommended that any new residue depletion studies intended for the lifting of the suspensions of the marketing authorisations are submitted to the CVMP for assessment.

No exit from the fleet supported by public aid shall be permitted unless preceded by the withdrawal of the fishing licence as defined in Council Regulation (EC) No 3690/93(10) and, where provided for, the fishing authorisations as defined in the relevant regulations.

Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Cerepro for the treatment of patients with operable high-grade glioma.

Commission Regulation (EC) No 2076/2002(3) contains provisions for the non-inclusion of certain active substances in Annex I to Directive 91/414/EEC and for the withdrawal by Member States of all authorisations for plant-protection products containing such active substances.

Council Regulation (EC) No 1756/2002 of 23 September 2002 amending Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of an additive and amending Commission Regulation (EC) No 2430/1999(2) is to be incorporated into the Agreement.

The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007 including presentation of a new residue study in pigs and a new calculation and proposal for the withdrawal period for pigs.

A Marketing Authorisation for Suramox 15 % LA was previously granted to Virbac S. A. in France on 6 July 2004 based on an abridged application having Duphamox LA as reference medicinal product, with a withdrawal period of 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.

Where a Member State submits comments to the Commission and to the Member State which granted the authorisation, which show that supplies are available during the period of the shortage, the Member State shall consider withdrawal of the authorisation or reducing the envisaged period of validity, and shall inform the Commission and the other Member States of the measures it has taken or will take, within 15 days days from the date of receipt of the information.

Commission Regulation (EC) No 2076/2002(2) and Commission Decision 2002/928/EC(3), contain provisions for the non-inclusion of certain active substances in Annex I to Directive 91/414/EEC and for the withdrawal by Member States of all authorisations for plant protection products containing those active substances.

Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances

It will be the responsibility of the authorities covered by the Annex to ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, which could affect the protection of public health, is communicated to the other Party with the appropriate degree of urgency as defined in the 'two-way` alert programme.

On 14 March 2007 the CVMP, having considered the new residue studies, concluded that it was not possible to set a withdrawal period for Suramox 15% LA and Stabox 15% LA, for either cattle or pig meat and offal and therefore recommended by consensus the suspension of the above marketing authorisations for the above-mentioned products.

providing the competent authorities with any other information relevant to the evaluation of the risks and benefits of a veterinary medicinal product, particularly information concerning post-authorisation safety studies, including information regarding the validity of the withdrawal period or lack of expected efficacy or potential environmental problems.

On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.

Based on the above data concerning withdrawal reactions and suicidal behaviour, UK considered that there was Community interest to reassess the balance of risks and benefits of paroxetine and requested the CHMP to give an opinion on whether the marketing authorisations for paroxetine containing medicinal products should be maintained, varied or withdrawn.

in the case of a product containing mepanipyrim as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2006 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

in the case of a product containing Coniothyrium minitans as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2005 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest."

in the case of a product containing Pseudomonas chlororaphis as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2006 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Taxotere/ Docetaxel Winthrop in the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.

Where necessary, they shall amend or withdraw the authorisation for each such plant protection product, by the deadline defined for such an amendment or withdrawal in the respective Directives which amended Annex I so as to add the relevant substances to it. Where the respective Directives set different deadlines, the deadline shall be the latest of the dates defined.

In the event of the withdrawal or lapse of the authorisation, the competent authority of the home Member State shall notify the competent authorities of the other Member States accordingly and they shall take appropriate measures to prevent the assurance undertaking from commencing new operations within their territories, under either the freedom of establishment or the freedom to provide services.

withdrawal periods for cattle and pigs are inadequate to ensure that foodstuffs obtained from the treated animals do not contain residues which might constitute a health hazard to the consumer; the CVMP recommends the suspension of the marketing authorisations for Suramox 15 % LA or variations of that name as referred in Annex I, presented as injectable suspension for pigs and cattle.

Commission Regulation (EC) No 2076/2002 of November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances(2) allows certain Member States to maintain in force, until 30 June 2007, authorisations for plant protection products containing certain substances, whose non-inclusion in Annex I to Council Directive 91/414/EEC(3) it provides for.

Where any of the relevant acts provide for Community procedures on the granting, suspension and withdrawal of a marketing authorisation as well as supervision, including pharmacovigilance, and inspections and sanctions, these and similar tasks shall be carried out by the competent authorities in the EFTA States, on the basis of the same obligations as those of the competent authorities of Community Member States.

Article 8(2), fourth subparagraph, of Directive 91/414/EEC provides for a Commission Decision not to include in Annex I active substances in cases where the requirements of Article 5 of Directive 91/414/EEC are not satisfied or the requisite information and data have not been submitted within the prescribed time period and for the withdrawal by Member States of authorisations of plant protection products containing such active substances.

Although it is not a prerequisite for the decision of the competent authority in the host Member State, the temporary or permanent withdrawal by the competent authority in the home Member State of the authorisation to practise the profession shall automatically lead to the lawyer concerned being temporarily or permanently prohibited from practising under his home-country professional title in the host Member State.

in the case of a product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2005 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest."

in the case of a product containing alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil or phenmedipham as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2009 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

in the case of a product containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate or silthiofam as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2005 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest."

Whereas, on the basis of current scientific and technical knowledge, it would appear, however, that the evidence presented by the Kingdom of Sweden does not justify withdrawal of the authorisations for the antibiotics monensin sodium and salinomycin sodium, of the ionophore group, since no ionophore is to date used in veterinary or human medicine and the two substances, in the current state of knowledge, do not select cross-resistance to antibiotics used in human or veterinary medicine;

For the purpose of trade, Member States may authorise the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in Articles 4, 5 or 5a and may authorise the affixing of the Community stamp to meat from such animals where the conditions laid down in Articles 4, 5 or 5a and the withdrawal periods provided for in the authorisation to place on the market are complied with."

The Marketing Authorisation Holders were requested in a list of questions to provide: • Justification of the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria. o Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; o If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data. o The Periodic Safety Update Reports for at least the last 3 years. • Justification of the withdrawal period, in case the recommended dose should increase.

it is therefore necessary to include in national law appropriate effective and systematic financial or equivalent administrative penalties - such as injunctions combined with administrative fines, reporting to supervisory authorities on a regular basis, on-the-spot checks, publications in the national official journal and in the press, suspension of the activities of the company (prohibition on the conclusion of new contracts for a certain period), designation of a special representative of the supervisory authorities responsible for monitoring that the business is run in line with insurance laws, withdrawal of the authorisation for this business line, sanctions to be imposed on directors and management staff - in the event that the insurance undertaking or its representative fails to fulfil its obligation to make an offer of compensation within a reasonable time-limit;