The export or re-export from the Community of specimens of the species listed in Annexes B and C shall be subject to completion of the necessary checks and the prior presentation, at the customs office at which the export formalities are completed, of an export permit or re-export certificate issued by a management authority of the Member State in whose territory the specimens are located.

In the light of past experience and taking into account that the Community concession provides for an overall quantity for four years with an annual maximum of 5500000 tonnes, it is advisable to maintain measures which, under certain conditions, either facilitate the release for free circulation of quantities of products exceeding those given in the import licences, or allow the difference between the figure given in the import licences and the smaller figure actually imported to be carried forward.

However, if at any time a Party decides not to require prior written consent, either generally or under specific conditions, for transit transboundary movements of hazardous wastes or other wastes, or modifies its requirements in this respect, it shall forthwith inform the other Parties of its decision pursuant to Article 13.

This Regulation lays down provisions for the application of Council Regulation (EC) No 3036/94 establishing economic outward processing arrangements applicable to certain textile and clothing products reimported into the Community after working or processing in certain third countries, hereinafter referred to as the 'basic Regulation`, especially with respect to the issue and control of prior authorizations.

Where, in connection with the processing of an application for a residence permit, the immigration authorities become aware of facts which give rise to a suspicion that the applicant has participated in crimes referred to in Article 1, and where it emerges that the applicant has previously sought permission to reside in another Member State, the law enforcement authorities may apply to the competent law enforcement authorities in the latter Member State with a view to obtaining relevant information, including information from the immigration authorities.

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.

'(a) applicants for import licences must be natural or legal persons who, at the time applications are submitted, can prove to the satisfaction of the competent authorities of the Member States that they imported not less than 100 tonnes (product weight) of products falling within CN codes 0207, 1602 31, 1602 32 and 1602 39 in each of the two previous calendar years.

licence applications presented in May 2004 by the traditional importers within the meaning of Article 4(1)(a) of Regulation (EC) No 2125/95 shall not relate to a quantity exceeding 65 % of the average annual quantity of imports originating in countries other than Poland, Bulgaria and Romania and effected under that Regulation in the three previous calendar years.

licence applications presented in January 2004 by the traditional importers within the meaning of Article 4(1)(a) of Regulation (EC) No 2125/95 shall not relate to a quantity exceeding 35 % of the average annual quantity of imports originating in countries other than Poland, Bulgaria and Romania and effected under that Regulation in the three previous calendar years;

Pending the outcome of the studies, the MAH committed to amend the SPC section 5.1 in order to update this section with the latest results from clinical studies regarding anti-HBs responses in individuals previously vaccinated and not vaccinated with Hepatitis B Vaccine as well as anti-PRP responses.

The obligations from the abovementioned Agreement as well as the mentioned requests for pre-export notifications for acetic anhydride and potassium permanganate can be complied with only in so far as prior export authorisation requirements are introduced for the substances and countries concerned listed in Annex A to the Agreement or referred to in the pre-export notification requests.

The additional amounts, provided for in Article 3 (4) (2) and (5) (4) of the basic Regulation, are allocated according to the maximum amounts shown in Annex III on the condition that the applicant has effectively either reimported at least 50 % or exported an equivalent of at least 80 % of the quantity previously authorized in the framework of the economic outward processing arrangements for the category and the country concerned.

whereas, in the light of experience, it should be possible for Member States to set the deadline for submission on their own responsibility without seeking the authorization of the Commission, taking into account in particular the time required for all relevant data to be available for the proper administrative and financial management of the aid and for checks to be carried out;

For species of special importance in the region defined in Annex II which are biologically sensitive by reason of their exploitation characteristics, fishing activity by Community fishing vessels of a length between the perpendiculars of not less than 26 metres, for demersal species other than Norway pout and blue whiting, shall be governed by a system of prior authorisation in accordance with the conditions laid down in this Regulation and, in particular, in Annex II.

'(a) Applicants for import licences must be natural or legal persons who, at the time applications are submitted, can prove to the satisfaction of the competent authorities that they have imported not less than 80 tonnes (product weight) of products falling within CN code 0207, 1602 31 or 1602 39 in the two calendar years preceding the year in which the licence application is lodged.

Moreover, at the request of the applicant, which must be made at the same time as application for the import licence, and on production of the relevant documentary proof, the competent authority shall reduce the security required in pursuance of the second and third subparagraphs of this paragraph to the amount of the security lodged, pursuant to Article 115 (5) of Regulation (EEC) No 2913/92, upon the prior exportation of the corresponding amount of white sugar.

For the textile products subject to quantitative limits referred to in Article 2 of the Regulation or to the surveillance measures with a double-checking system referred to in Annex III, Member States shall notify the Commission within the first 10 days of each month of the total quantities, in the appropriate units and by country of origin and category of products, for which import authorizations have been issued during the preceding month.

A marketing authorization shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorized, according to national legislation, to use such medicinal products in an approved health care establishment exclusively from authorized radionuclide generators, radionuclide kits or radionuclide precursors in accordance with the manufacturer's instructions.

'(a) Applicants for import licences must be natural or legal persons who, at the time applications are submitted, can prove to the satisfaction of the competent authorities in the Member States that they have imported or exported not less than 50 tonnes (product weight) or exported not less than 500 tonnes (product weight) of products falling within CN code 0207, 1602 31 or 1602 39 in the two calendar years preceding the year in which the licence application is lodged.

Whereas in cases other than those provided for in Article 11 (3) of Regulation (EC) No 3036/94, the granting of prior authorizations is subject to the quantities being available in accordance with the procedures laid down in Annex VII to Council Regulation (EEC) No 3030/93 of 12 October 1993 on common rules for imports of certain textile products from third countries (2), as last amended by Commission Regulation (EC) No 1616/95 (3);

Without prejudice to paragraphs 3 and 4, a host Member State shall, for the purpose of admission to the occupation of road transport operator, accept as sufficient proof of good repute or of no previous bankruptcy an extract from a judicial record, or failing that, an equivalent document issued by a competent judicial or administrative authority in the road transport operator's country of origin or the country whence he comes, showing that these requirements have been met.

If the acquirer of any holding referred to in paragraph 3 is an investment firm, a credit institution, an insurance undertaking or a UCITS management company authorised in another Member State, or the parent undertaking of an investment firm, credit institution, insurance undertaking or a UCITS management company authorised in another Member State, or a person controlling an investment firm, credit institution, insurance undertaking or a UCITS management company authorised in another Member State, and if, as a result of that acquisition, the undertaking would become the acquirer's subsidiary or come under his control, the assessment of the acquisition shall be subject to the prior consultation provided for in Article 60.

For the purpose of this Article the provision of such evidence shall consist in presentation to the competent authority of either a copy of a certificate of payment of value added tax in the Member State concerned or a copy of either a customs clearance certificate issued by the Member State concerned in respect of an import or export licence or an invoice relating to intra-Community trade in the applicant's name for an operation conducted in any of the three preceding years.

By way of derogation from Chapter I, Section 2 of Title 2 of Regulation (EC) No 2535/2001, operators established in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia (hereinafter "new Member States") may apply for import licences for the quotas covering the period 1 May to 30 June 2004 without prior approval of the competent authorities of the Member State in which they are established.

Prior regulations and/or specific authorization of discharges from urban waste water treatment plants made pursuant to paragraph 2 within agglomerations of 2 000 to 10 000 p.e. in the case of discharges to fresh waters and estuaries, and of 10 000 p.e. or more in respect of all discharges, shall contain conditions to satisfy the relevant requirements of Annex I B. These requirements may be amended in accordance with the procedure laid down in Article 18.

Member States shall ensure that by 31 December 2000 biodegradable industrial waste water from plants belonging to the industrial sectors listed in Annex III which does not enter urban waste water treatment plants before discharge to receiving waters shall before discharge respect conditions established in prior regulations and/or specific authorization by the competent authority or appropriate body, in respect of all discharges from plants representing 4 000 p.e. or more.

'fishing licence and special fishing permit of a fishing vessel flying the flag of a third country' means an attestation from the Commission giving the minimum data concerning the identification, technical characteristics and fitting out of that vessel, supplemented by a prior authorization enabling it to carry out its activities in Community fishing waters in accordance with the relevant provisions of Community law and the fisheries agreement concluded with the country in question.

Notwithstanding paragraph 1, hunters, in respect of categories C and D, and marksmen, in respect of category B, C and D, may without prior authorization be in possession of one or more firearms classified in these categories during a journey through two or more Member States with a view to engaging in their activities, provided that they are in possession of a European firearms pass listing such firearm or firearms and provided that they are able to substantiate the reasons for their journey, in particular by producing an invitation.

For medicinal products falling within the scope of Part A of the Annex to Council Regulation (EEC) No 2309/93 of 22 July 1993 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(6), which include products intended for gene therapy or cell therapy, prior scientific evaluation by the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as the "Agency"), assisted by the Committee for Proprietary Medicinal Products, is mandatory before the Commission grants marketing authorisation.

The Member States' obligation not to subject access to the activity of an information society service provider to prior authorisation does not concern postal services covered by Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service(23) consisting of the physical delivery of a printed electronic mail message and does not affect voluntary accreditation systems, in particular for providers of electronic signature certification service.

The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course - or a course recognized as equivalent by the Member State concerned - in a scientific discipline allowing him to engage in the activities of the person referred to in Article 48 in accordance with the laws of that State may - if he began his course prior to 21 May 1975 - be considered as qualified to carry out in that State the duties of the person referred to in Article 48 provided that he has previously engaged in the following activities for at least two years before 21 May 1985 following notification of this directive in one or more undertakings authorized to manufacture:

The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course - or a course recognized as equivalent by the Member State concerned - in a scientific discipline allowing him to engage in the activities of the person referred to in Article 48 in accordance with the laws of that State may - if he began his course prior to 21 May 1975 - be considered as qualified to carry out in that State the duties of the person referred to in Article 48 provided that he has previously engaged in the following activities for at least two years before 21 May 1985 following notification of this directive in one or more undertakings authorized to manufacture: production supervision and/or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of the person referred to in Article 48 to ensure the quality of the medicinal products.

The offer and marketing of services concerning the distribution to the public, through telecommunication or other information means, of information concerning prices, the volume of transactions, the offer and demand conditions relating to the negotiation of securities dealt in the Italian regulated market, or in other recognized markets, requires prior authorization by the Stock Exchanges Commission (Consob).

after a period of one month following prior notification, authorisation is tacitly granted unless the Minister of Economic Affairs has, in exceptional circumstances, exercised its right to postpone the investment.

after a period of one month following prior notification, authorisation is tacitly granted for other investments unless the Minister of Economic Affairs has, in exceptional circumstances, exercised its right to postpone the investment.

Whereas the Member States must inform the Commission of the import licence applications received, in accordance with the procedure laid down in Article 8 of Regulation (EC) No 520/94; whereas the information about traditional importers' previous imports must be broken down by reference year and expressed in the same units as the quota in question; whereas if the quota is set in ecus, the counter-value of the currency in which previous imports are expressed must be calculated in accordance with Article 18 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code ( fn );