manufacturing authorization for the medicinal product concerned,

This manufacturing authorization shall be required nothwithstanding that the medicinal products manufactured are intended for export.

Manufacturing authorisation issued by the French Ministère des Affaires Sociales, Ministère délégué à la Santé, and the Ministère de l’ Agriculture et de la Forêt on 31 March 1992.

Licensing or authorization of the manufacture of parts and components shall be in accordance with domestic law;

Each Party shall endeavour to adopt and implement further measures including licensing, where appropriate, to control or regulate the production and distribution of tobacco products in order to prevent illicit trade.

(b) to domestic organizations permitted or licensed by the receiving Party to construct or operate nuclear production or utilization facilities, or to use nuclear materials and radiation sources, provided that such proprietary information is used only within the terms of the permit or license; and

(2) to domestic organizations permitted or licensed by the receiving Party to construct or operate nuclear production or utilization facilities, or to use nuclear materials and radiation sources, provided that such proprietary or other confidential or privileged information is used only within the terms of the permit or license; and

Manufacturing authorization, if any.

"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;

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

Such a derogation shall be granted by 31 July 2002 and shall involve permission being granted for the areas concerned to produce wine which is to be marketed.

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.

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

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.

The extension of the ten-year period to 11, 12, or 13 years for a veterinary medicinal product intended for food-producing species shall be granted only if the marketing authorisation holder also originally applied for determination of the maximum residue limits established for the species covered by the authorisation.

A veterinary medicinal product may not be the subject of a marketing authorisation for the purpose of administering it to one or more food-producing species unless the pharmacologically active substances which it contains appear in Annexes I, II or III to Regulation (EEC) No 2377/90.

In the veterinary sector, if no medicinal product has been authorised for a given species or a given disorder, the possibility of using other existing products should be made a straightforward matter, but without prejudicing consumer health in the case of medicinal products intended for administration to food-producing animals.

the existing permission for new planting to produce a quality wine produced in specified regions (quality wine psr) and table wine described by reference to a geographical indications has proved to be a useful component of the quality policy which is designed to better align supply on demand;

At the request of the competent authorities, applicants shall supply any further substantiation which the authorities consider necessary for the issuing of licences and shall accept, where applicable, any checks by those authorities of the bookkeeping and manufacturing conditions of the products concerned.

In the case of veterinary medicinal products which are intended for one or more food-producing species but whose pharmacologically active substances have not yet been included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a marketing authorisation may not be applied for until after a valid application has been made for the establishment of maximum residue limits in accordance with that Regulation.

undertake in writing to provide, at the request of the competent authorities, any further substantiation which the latter consider necessary for the issuing of licences and to accept, where applicable, any checks by those authorities on the book-keeping and manufacturing conditions of the products concerned.

undertake in writing to provide, at the request of the competent authorities, any further substantiation which the latter consider necessary for the issuing of licences and to accept, where applicable, any checks by those authorities of the book-keeping and manufacturing conditions of the products concerned.

Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a non food-producing species, by way of exception, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animal concerned with:

Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing species, by way of exception, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned on a particular holding with:

Technical assistance shall be subject to controls (prohibition or an authorisation requirement) adopted pursuant to Article 5 where it is provided outside the European Community by a natural or legal person established in the European Community and is intended, or the provider is aware that it is intended, for use in connection with the development, production, handling, operation, maintenance, storage, detection, identification or dissemination of chemical, biological or nuclear weapons or other nuclear explosive devices or the development, production, maintenance or storage of missiles capable of delivering such weapons.

(i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing fishmeal is not required for home compounders:

(i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing hydrolysed proteins is not required for home compounders:

(i) a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing dicalcium phosphate or tricalcium phosphate is not required for home compounders:

'undertaking in the explosives sector' shall mean any natural or legal person possessing a licence or authorization which entitles him to engage in the manufacture, storage, use, transfer or trade in explosives,

any suspension or withdrawal of a manufacturing authorisation.

payments for government licences and fees that are treated as taxes on production (see paragraphs 4. 79 to 4. 80).

Licences granted for products other than the product concerned, can also be used to import inputs that enter directly or indirectly in the production of PTY.

Whereas the first paragraph of Article 1 of Regulation (EEC) No 2204/90 stipulates that the use of casein and caseinates in the manufacture of cheese is subject to prior authorization;

The production of nuclear energy for peaceful purposes shall only be performed by the Chilean Nuclear Energy Commission or, with its authorisation, in conjunction with third parties.

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

The use of casein and caseinates in the manufacture of cheese shall be subject to prior authorization, which shall be granted only if such use is a necessary condition for the manufacture of the products.

amending Regulation (EC) No 2019/94 as regards the licences required to import residues made from the manufacture of starch from maize from the United States of America

any pre-mix for the manufacture of medicated feedingstuffs as defined in Article 1 (2) of Directive 81/851/EEC which has been granted an authorization in accordance with Article 4 of that Directive;

However, it is necessary, for both public health and economic reasons, to prohibit the use of unauthorized medicinal products in the manufacture of medicated feedingstuffs.

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 ( ΡΟΥ ), which is the main input that entered in the production of PTY. ΡΟΥ was produced in three different units and was sold as a finished product or used for the production of different products.

For producer units, ESA 95 restricts the recording of the licences and fees paid to government to be recorded under other taxes on production to a narrower range of payments than does ESA 79.

In ESA 95 sales and purchases of licenses for the use of intangible non-produced assets (patents, trade marks, copyrights, etc.) are recorded under output and consumption respectively.

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.

At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the manufacturer:

a) The description of the manufacturing method accompanying the application for Marketing Authorisation pursuant to Article 8 (3) (d), shall be drafted in such a way as to give an adequate synopsis of the nature of the operations employed.

The provisions of paragraph 1 shall apply provided that the medicinal product, where administered to food-producing animals, contains only substances to be found in a veterinary medicinal product authorized for such animals in the Member State concerned and that in the case of food-producing animals the veterinarian responsible specifies an appropriate withdrawal period.

8. An export authorisation may be suspended or revoked by the competent authorities whenever there are reasonable grounds for suspecting that the substances might be diverted to the illicit manufacture of narcotic drugs or psychotropic substances.

This is justified where the production in respect of which an aid application has been made corresponds to a much higher yield than that estimated for the zone concerned, or where a proposal has been made to withdraw approval from the mill in question for at least one year.

(a) a Community procedure for the evaluation and authorisation of primary smoke condensates and primary tar fractions for use as such in or on foods or in the production of derived smoke flavourings for use in or on foods;