whereas, as regards products originating in Vietnam, in accordance with the practice followed for several years, import licence applications are subject, in addition to other provisions, to presentation of a certificate issued on the initiative of the exporting country;

These certify the marketing authorisation and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries.

If the procedure for reaching the agreement referred to in paragraph 1 does not enable the authorizing authority to decide on an application, the matter may be referred to the Commission within the time limit of five months calculated from the date of submission of the application by the carrier.

Whereas, for the sake of sound management of the import arrangements in question, applications for licences may not cover a quantity in excess of that entered on the document certifying loading and shipment to the Community;

The competent authorities shall establish a provisional specific allocation for each non-traditional operator registered with them by multiplying the quantity in each operator's application by a coefficient of 0,29 with a view to issuing licences in May 2004.

In order to ensure transparency of the permitting process throughout the Community the public should have access to information with a view to allowing it to be involved in decisions to be taken following applications for new permits and their subsequent updates.

whereas transboundary consultation is to be organized where applications relate to the licensing of new installations or substantial changes to installations which are likely to have significant negative environmental effects;

The Commission shall ensure that a decision is taken, in accordance with the procedure laid down in Article 23, on the application for Community authorization within 320 days following its inclusion on the agenda for the Standing Committee for Feedingstuffs in accordance with the second subparagraph of paragraph 4.

However, where the application for an import licence relates to only a part of the quantity indicated on the export certificate, the issuing body shall indicate on the original the quantity for which it was used and, after affixing its stamp, shall return it to the party concerned.

Moreover, in order to monitor the benefit/risk assessment after marketing authorization has been granted, any change to the data in the dossier, any new information not in the original application and all pharmacovigilance reports, shall be submitted to the competent authorities.

The competent authority may submit samples of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 19, or after a marketing authorization has been granted.

However, where the import licence applications cover only part of the quantity indicated on the export licence, the issuing authority shall indicate on the original the quantity in respect of which the original was used and, after stamping it, shall return the original to the party concerned.

It is necessary to provide for uniform models for transport documents such as the control document for liberalised occasional services and also the authorisation and the application form for non-liberalised services in order to facilitate and simplify inspection procedures.

For quantities not covered by import licences issued under the September tranche, import licence applications may be submitted in respect of all countries of origin covered by the relevant quota under an additional tranche in October pursuant to Article 4(1), except as regards the quantities set out in paragraph 1(c) above.

On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma.

Pharmacovigilance system The MAH must ensure that the system of Pharmacovigilance, as described in version dated June 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the Market.

The Chief Fisheries Officer and the shipowners shall keep a copy of fax communications or e-mail messages until both parties have agreed to the final statement of fees due referred to at point 2 (Licence application and issuing formalities).

To provide the dossier submitted upon application for a marketing authorisation, for each Member State mentioned above (including Germany) and, if applicable, for any other Member State or country of the European Economic Area (EEA): a.

Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.";

The flag Member State shall send the Commission all applications for the issue to vessels flying its flag of third-country fishing licences to carry on fishing activities under the fishing possibilities granted to the Community pursuant to a fisheries agreement with a third country.

APPLICATION FOR LICENCES FOR TUNA VESSELS AND LONGLINERS SHALL BE ISSUED FOLLOWING PAYMENT TO THE ACCOUNTANT GENERAL'S DEPARTMENT OF THE GAMBIA OF A LUMP SUM OF 1 000 ECU A YEAR FOR EACH TUNA SEINER, 200 ECU A YEAR FOR EACH POLE AND LINE TUNA VESSEL, AND 200 ECU A YEAR FOR EACH LONGLINER, EQUIVALENT TO THE FEES FOR :

Without prejudice to Article 5(3) and (5) and Article 17(3) and (5) of Regulation (EC) No 1829/2003, and taking into account the guidance of the European Food Safety Authority (the Authority) provided for in Articles 5(8) and 17(8) of that Regulation, applications for authorisation submitted in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (the applications) shall comply with the requirements of paragraphs 1 to 4 of this Article and with Articles 3 and 4 of this Regulation.

Whereas it is therefore desirable that a system for the mutual exchange of information should be established and that Member States and the Commission should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorisation of biocidal products;

Where a request submitted under Article 4 of Directive 70/524/EEC, concerning products referred to in Article 15(1) of Regulation (EC) No 1829/2003, is supplemented by an application under Regulation (EC) No 1829/2003, in accordance with Article 46(5) of that Regulation, the Member State acting as rapporteur shall ask the applicant without delay to submit a separate application for authorisation in accordance with Article 17 of Regulation (EC) No 1829/2003.

Article 9c(3) of Council Directive 70/524/EEC provides that 10 years after a substance has first been authorised, the findings of all or part of the evaluation of data and information contained in the dossier supplied for initial authorisation may be used for the benefit of other persons seeking authorisation to put that substance into circulation.

On 21 May 2007, Protherics PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Voraxaze, for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.

This chapter provides detailed rules concerning applications for authorisation submitted in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, including applications submitted under other Community legislation which are transformed or supplemented in accordance with Article 46 of that Regulation.

Whereas, in order to inform the public of the operation of installations and their potential effect on the environment, and in order to ensure the transparency of the licensing process throughout the Community, the public must have access, before any decision is taken, to information relating to applications for permits for new installations or substantial changes and to the permits themselves, their updating and the relevant monitoring data;

Owing to the new legislation, the Agency expects to receive the first authorisation applications for generic medicines this year, and will assume full responsibility for evaluating medicines intended for the treatment of HIV/ AIDS, cancer, diabetes and neurodegenerative disorders, which must now be authorised through the centralised procedure.

On 17 May 2006, CIS bio international has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for SCINTIMUN, for diagnostic imaging to determine the location of infectious or inflammatory lesions and to detect metastases (when cancer spreads) in bone marrow.

On 1 August 2008, Pharmion Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Orplatna, for the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy.

the conditions and requirements concerning the exercise or termination of the activity which apply to each type of authorizations by virtue of the laws, regulations and administrative provisions in force at the time of submission of the applications, whether contained in the authorization or being one of the conditions to be accepted prior to the grant of such authorization, are established and made available to interested entities at all times.

In order to ensure that quantities for which import authorizations are issued do not exceed at any moment the total quantitative limits for each product group, the competent authorities shall issue import authorizations only upon confirmation by the Commission that there are still quantities available within the quantitative limits for the relevant product group of steel products in respect of the supplier country, for which an importer or importers have submitted applications to the said authorities.

Licence applications shall only be admissible where the applicant declares in writing that he has not submitted, and undertakes not to submit, any other applications under the import arrangements referred to in Article 1, in respect of the current period, concerning the same product by code and country of origin in the Member State in which his application is lodged or in other Member States;

If two or more applications submitted in accordance with Articles 12 to 14 have been made for marketing authorisation for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorisation of that veterinary medicinal product, or suspension or revocation of authorisation, a Member State, or the Commission, or the marketing-authorisation holder may refer the matter to the Committee for Medicinal Products for Veterinary Use, hereinafter referred to as 'the Committee', for the application of the procedure laid down in Articles 36, 37 and 38.

After the marketing authorisation has been granted, the marketing authorisation holder may allow use to be made of the pharmaceutical, safety and residues, pre-clinical and clinical documentation contained in the file for the veterinary medicinal product with a view to examining a subsequent application for a veterinary medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form.

Where a marketing authorisation in respect of an orphan medicinal product is granted pursuant to Regulation (EEC) No 2309/93 or where all the Member States have granted marketing authorisations in accordance with the procedures for mutual recognition laid down in Articles 7 and 7a of Directive 65/65/EEC or Article 9(4) of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(7), and without prejudice to intellectual property law or any other provision of Community law, the Community and the Member States shall not, for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product.

Member States may authorise the use of the journey forms, applications for authorisation, authorisations and certificates drawn up in conformity with Regulation (EEC) No 1839/92 and with Regulation (EEC) No 2454/92 until 31 December 1999 at the latest, provided that they are amended, legibly, indelibly and appropriately in so far as is necessary, in order to conform to Regulations (EEC) No 684/92, (EC) No 12/98 and this Regulation.

Directive 2001/83/EC(4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.

Whenever such scientific authority determines that the export of specimens of any such species should be limited in order to maintain that species throughout its range at a level consistent with its role in the ecosystem in which it occurs, and well above the level at which that species might become eligible for inclusion in Annex A in accordance with Article 3 (1) (a) or (b) (i), the scientific authority shall advise the competent management authority, in writing, of suitable measures to be taken to limit the issuance of export permits for specimens of that species.

Whenever such scientific authority determines that the export of specimens of any such species should be limited in order to maintain that species throughout its range at a level consistent with its role in the ecosystem in which it occurs, and well above the level at which that species might become eligible for inclusion in Annex A in accordance with Article 3 (1) (a) or (b) (i), the scientific authority shall advise the competent management authority, in writing, of suitable measures to be taken to limit the issuance of export permits for specimens of that species

Whereas for the purposes of quota allocation, a time limit must be set for the submission of licence applications by traditional and other importers;

In that case they shall indicate in their licence application the aggregate value of imports of the product in question in each of the years in the reference period.

except in the case of import licence applications for products falling within CN code 6402 99, applicants already holding import licences issued under Commission Regulation (EC) No 1012/94 ( fn ) or Commission Regulation (EC) No 2801/94 ( fn ) for products covered by the licence application may enclose a copy of their previous licences with their licence applications.

Whereas with a view to optimum use of quotas, licence applications for imports of footwear under quotas which refer to several CN codes must specify the quantities required for each code;

The portion of the second tranche set aside for non-traditional importers in respect of products falling within CN codes 6403 51, 6403 59 and 8527 29 shall be set aside for non-traditional importers who submitted an import licence application for the first tranche of the 1995 quota.

Applications for import licences shall be lodged from the day following the day of publication of this Regulation in the Official Journal of the European Communities to 18 April 1995 at 5 p.m., Brussels time, with the competent authorities listed in Annex I to Regulation (EC) No 738/94.

On the further application of the trader within 15 working days of the entry into force of this Regulation and subject to the lodging of the security applicable, provisional export licences may be issued for further quantities in so far as the application of the coefficient in column 7 of the Annex to the quantity applied for allows.

In application of the relevant EC Directives, Member States will make their best endeavours to consider within 12 months complete applications for licenses to conduct banking activities, through the establishment in a Member State of a subsidiary in accordance with the legislation of that Member State, by an undertaking governed by the laws of Chile.

Member States will make their best endeavours to respond without undue delay to requests for information by applicants on the status of complete applications for licenses to conduct banking activities, through the establishment in a Member State of a subsidiary in accordance with the legislation of that Member State, by an undertaking governed by the laws of Chile.