The holder of a manufacturing authorization shall at least be obliged:

The authorization issued by the competent authority to transport eggs from a suspect holding subject to the provisions of Article 4 (2) (e) to an establishment approved for the manufacture and processing of egg products in accordance with the provisions of Article 6 (1) of Directive 89/437/EEC, hereinafter called the designated establishment, must meet the following conditions:

Any excess over 8 % and up to 20 % in any year, or any excess in the first and subsequent years following two consecutive years in which excesses occur, shall be negotiated with the Authority, which may require the operator to obtain a supplementary production authorisation to cover additional production.

29/ 42 Name and address of the Manufacturing Authorisation Holder responsible for batch release

"exclusive territory" means a territory in which only one undertaking is allowed to produce the contract products with the licensed technology, without prejudice to the possibility of allowing within that territory another licensee to produce the contract products only for a particular customer where this second licence was granted in order to create an alternative source of supply for that customer;

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA

1. NAME AND ADDRESS OF THE MARKETING AUTHORSATION HOLDER AND OF THE MANUFACTURING AUTORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

This period shall not, however, exceed a total of 13 years, for a marketing authorisation for four or more food-producing species.

The capacity authorized by the administration should not differ greatly from actual production.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT

NAME OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT

to prepare and submit to the Council applications for production authorisations in accordance with Article 151(2) to (7);

Name and address of the Manufacturing Authorisation Holder responsible for batch release Intervet International B. V.

Company B is granted a license for the exclusive production and distribution of the resulting product for the duration of the patent.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

any production to meet the essential uses in the Community, licensed in accordance with Article 3(4),

Manufacturer for the batch release:Pfizer NV/SA Rijksweg 12 B-2870 Puurs Belgium

make the selection from among applicants for production authorisations pursuant to Annex III, Article 7, where such selection is required by that provision;

The manufacturers shall ensure that the manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorization.

An operator may in any year produce less than or up to 8 % more than the level of annual production of minerals from polymetallic nodules specified in his production authorisation, provided that the overall amount of production shall not exceed that specified in the authorisation.

Applicants which are not selected in any period shall have priority in subsequent periods until they receive a production authorisation.

Member States shall take all appropriate measures to ensure that the manufacture or importation of investigational medicinal products is subject to the holding of authorisation.

Applications for such supplementary production authorisations shall be considered by the Authority only after all pending applications by operators who have not yet received production authorisations have been acted on and due account has been taken of other likely applicants.

This is the fee for an application for a Community authorization to market a medicinal product for use in food producing animals supported by a full dossier.

EPCG licences have been obtained by this exporting producer not only to produce the product concerned (PTY), but also to produce other products like polyester oriented yarn (POY), which is the main input that entered in the production of PTY.

60 % of the difference between the trend line values for nickel consumption, as calculated pursuant to subparagraph (b), for the year for which the production authorisation is being applied for and the year immediately prior to the year of the earliest commercial production.

27/ 35 Manufacturing authorisation holder responsible for batch release Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest

Implementing rules concerning applications for authorisation of feed additives should take into account different documentation requirements for food-producing and other animals.

If the operator's application for a production authorisation is denied pursuant to subparagraph (d), the operator may apply again to the Authority at any time.

In the application for the production authorisation, the operator shall specify the annual quantity of nickel expected to be recovered under the approved plan of work.

Manufacturing authorisation holder responsible for batch release MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F-69800 SAINT PRIEST FRANCE

calculate the production ceiling and issue production authorisations on behalf of the Authority pursuant to Article 151(2) to (7), following any necessary selection among applicants for production authorisations by the Council in accordance with Annex III, Article 7.

The authorization referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.

At the request of the manufacturer, the exporter or the authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of the manufacturing authorization.

Possession of an authorization to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to possess a manufacturing authorization and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary.

Member States shall ensure that authorisation procedures for small and/or distributed generation take into account their limited size and potential impact.

in approved establishments, the preparation of egg products from raw materials which are not suitable for the manufacture of foodstuffs is prohibited, even for non-food purposes.

Upon issue of import licences for the products referred to in the 1981 Agreement, care must be taken to ensure a fair distribution of the licences among the various Republics, paying particular attention to the distribution of production among those Republics.

Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements for the manufacturing authorizations or marketing authorizations are fulfilled.

Nearly all Member States have chosen to ensure competition in the electricity generation market through a transparent authorisation procedure.

inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20;

If the approved date of commencement of commercial production is postponed because of a delay in issuing the production authorisation, in accordance with Article 151, the annual fixed fee shall be waived for the period of postponement.

In the case of veterinary medicinal products intended for one or more food-producing species and containing a new active substance that has not been authorised in the Community by 30 April 2004 the ten-year period provided for in the second subparagraph of paragraph 1 shall be extended by one year for each extension of the marketing authorisation to another food-producing species, if it is authorised within the five years following the granting of the initial marketing authorisation.

If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies in accordance with Regulation (EEC) No 2377/90, together with further clinical trials, it shall not be permissible for a third party to use such studies or such trials pursuant to Article 13, for a period of three years from the grant of the authorisation for which they were carried out.

the specific name of the additive in accordance with the authorization given, the active substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture;

specific name given to the additive upon authorization, active substance level and expiry date of the guarantee of that level or storage life from the date of manufacture;

the specific name given to the additive upon authorization, the active substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture;

whereas it is necessary for particular conditions of access in the case of export licences for certain traditional markets in order to limit speculative applications which could put at risk the production which is specifically destined for those markets for a transitional period;

a veterinary medicinal product authorised in another Member State in accordance with this Directive for use in the same species or in another food-producing species for the condition in question or for another condition; or

specific name given to the additive upon authorization, alpha-tocopherol level and expiry date of the guarantee of that level or storage life from the date of manufacture;