Key Benefits:
The Prime Minister,
On the report of the Minister of Solidarity, Health and The family and the Minister of Agriculture, Food and Fisheries And rurality,
Having regard to Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001, as amended by Directive 2004 /28/EC of the European Parliament and of the Council of 31 March 2004 establishing a Community code relating to medicinal products Veterinarian;
Having regard to Council Directive 90 /167/EEC of 26 March 1990 laying down the conditions for the preparation, placing on the market and use of medicated feed in the Community;
Having regard to Regulation No 2913/92 of the Council of 12 October 1992 establishing a Community Customs Code;
Seen the Customs code;
Given the code of public health;
Given the rural code;
Given the general tax code, in particular Article 277 A;
In view of Act No. 2000-321 of 12 April 2000 on the rights of citizens in their relations with Authorities, and in particular Articles 22 and 23;
In view of the notification to the European Commission n ° 2002 /331/F of 20 August 2002;
In view of Opinion No. 04-A-10 of the Competition Council dated 15 June 2004;
In view of the opinion of the French Agency Food safety as of 20 August 2004;
The Council of State (section Social) heard,
Clipping:
Article R. 5141-123 of the Public Health Code is replaced by the following:
" Art. R. 5141-123. -I.-Any veterinary medicinal product other than those mentioned in 1 ° and 2 ° of Article L. 5142-7 which does not have one of the marketing authorisations referred to in Article L. 5141-5, or of the registration referred to in Article L. 5141-9, Or the temporary use authorization referred to in Article L. 5141-10 shall, before importation, be subject to an import permit.
" The authorization to import is issued by the Director General of the French Food Safety Agency. This authorization is granted either under the conditions set out in R. 5141-123-2 to R. 5141-123-5, or under the parallel import authorization set out in R. 5141-123-6 to R. 5141-123-19. It shall be refused if the veterinary medicinal product presents or is likely to present a risk to human health or animal
. The import authorization granted under the conditions set out in R. 5141-123-2 to R. 5141-123-5 shall be suspended or deleted by the Director General of the French Food Safety Agency if the veterinary medicinal product Presents or is likely to present a risk to human health or animal health. Except in the case of an emergency, such decisions shall only take place after the holder of the authorisation has been placed to submit his
. II. -Except in the case of the use of a parallel import authorisation procedure or in the case of the importation of a veterinary medicinal product for the purpose of a clinical trial, an experiment or a manufacturing operation, the use of the import of a veterinary medicinal product Veterinary medicinal product by a means other than personal transport by the person in charge of the care of the animal or animals and subject to a compulsory requirement shall be prohibited except where the medicinal product comes from another Member State of the European Community and where there is no veterinary medicinal product in France Having an authorisation for this species and for this therapeutic indication, or veterinary medicinal product having authorisation for the treatment of animals of another species but for the same therapeutic indication, or veterinary medicinal product Having an authorization for the treatment of animals of the same species or of another species but for a different therapeutic condition. "
After item R. 5141-123 of the Public Health Code, the following items are inserted:
" Art. R. 5141-123-1. -is not subject to import authorisation, by way of derogation from Article R. 5141-123, the importation of veterinary medicinal products exclusively to animals whose flesh or products are not intended for human consumption, The following conditions are met:
" (a) Veterinary medicinal products shall be transported personally by the person responsible for the care of the animal or animals to which they are intended;
" (b) The person responsible for the care of the animal shall be accompanied by the animal or animals to which the medicinal products are intended;
" (c) The importation relates only to veterinary drugs other than immunological;
" (d) The imported quantity is compatible with therapeutic use for a period of treatment not exceeding three months under normal conditions of employment or during the treatment period prescribed by the order prescribing the drug Veterinarian.
" Art. R. 5141-123-2. -An import authorisation is required for each import operation involving veterinary medicinal products which have undergone all stages of manufacture, including
. By way of derogation from the provisions of the previous subparagraph, veterinary medicinal products at an intermediate stage of manufacture shall be granted authorisation for a series of import operations envisaged for a period of up to one year and for a period of Given global quantity.
" The same applies to veterinary medicinal products intended to be stored in a national export warehouse referred to in Article 277 A of the General Tax Code, as well as for veterinary medicinal products imported by the Head of the Guard of animal or animals.
" In this case, the authorisation shall specify the number of transactions provided for, the duration of the period during which the operations may be carried out and the total quantity of the veterinary medicinal product considered to be imported; Period of authorisation, the renewal shall be obtained only on presentation of the previous authorisation and indication of the operations carried out and the quantity imported during the period
The authorisation shall be returned to the French Food Safety Agency as soon as the import operations end and at the latest at the end of the period covered by that authorisation, bearing the reference to the quantities Effectively imported and the corresponding operations dates.
" Art. R. 5141-123-3. -I.-The request for an import authorisation addressed to the Director General of the French Food Safety Agency states: '
' (a) The name or name, address and quality of the natural or legal person responsible for the importation;
" (b) The country of origin and, if it is separate, the country in which the veterinary medicinal product was manufactured, and if applicable the name and address of the manufacturer;
" (c) The name of the veterinary medicinal product imported, its composition, pharmaceutical form, dosage, route of administration and animal or animals of destination;
" D) Imported quantities;
" (e) The desired duration of import operations;
" F) The purpose of the import.
" II. -The request is introduced:
" A) By a veterinarian or pharmacist, at the request of the person in charge of the animal or animal care, for medicinal products intended for animals whose flesh or products are intended for human consumption or for medicinal products Veterinary medicinal products intended for animals whose flesh or products are not intended for human consumption and subject to a mandatory requirement in accordance with French law;
" (b) Directly by the person responsible for the care of animals or animals, for veterinary medicinal products intended for animals whose flesh or products are not intended for human consumption and not subject to a prescription Required in accordance with French law;
" (c) By the pharmacist or veterinarian in charge of a veterinary medicinal facility referred to in Article L. 5142-1;
" (d) By the sponsor of a clinical trial or by the person responsible for an
. III. -This request shall include, in addition, the following information or parts:
" 1 ° For veterinary medicinal products imported for the purpose of a clinical trial, the name and address of the veterinary medicinal establishment which carries out the import or distribution operations authorised under Article L. 5142-2.
" 2 ° For veterinary medicinal products imported for the purpose of a non-clinical trial, the justification and protocol of the experiment, the copy of the authorisation to experiment provided for in Article R. 214-93 of the Rural Code obtained by the person responsible for The experimentation and the copy of the test establishment's approval under R. 214-103 of the same code.
" 3 ° For veterinary medicinal products covered by the regulation of narcotic drugs or psychotropic substances, a copy of the authorisation of the Director-General of the French Health Safety Agency provided for in Article R. 5132-78 or By R. 5132-92.
" 4 ° For veterinary medicinal products imported, under the conditions laid down in Chapter II of this Article, the order prescribing the veterinary medicinal product under the provisions of Article L. 5143-4
5 ° For medicated feeds other than those referred to in Article L. 5142-7:
" (a) The name of the medicinal premix, its composition, the animals of destination and, where appropriate, the copy of the marketing authorisation issued by the State of origin;
" (b) The name of the medicinal product, the rate of incorporation of the premix, the qualitative and quantitative composition of the food
. Art. R. 5141-123-4. -The silence kept by the Director General of the French Food Safety Agency shall be refused authorization at the expiration of forty-five days from the date of receipt of the full application referred to in R. 5141-123-3.
" The period referred to in the preceding subparagraph shall be reduced to twenty days when the application for authorisation relates to the importation of veterinary medicinal products authorised and issued in a Member State of the European
. The time limits referred to in the first two paragraphs shall be extended by 15 days if the Director General of the French Food Safety Agency requires the applicant to provide the additional information necessary for the inquiry Of the application, in order, in particular, to assess the risk to human health or animal
. Art. R. 5141-123-5. -The copy of the import authorisation or of the temporary use authorisation referred to in Article L. 5141-10 shall be presented at the time of the inspection by customs
. For veterinary medicinal products imported with the marketing authorisation referred to in Article L. 5141-5 or of the registration referred to in Article L. 5141-9, customs officers shall control the authorisation number to be placed on the Corresponding market or record that appears on packaging.
" Art. R. 5141-123-6. -Constitutes a parallel importation, with a view to placing on the market in France, the importation of a veterinary pharmaceutical specialty:
" 1 ° Who comes from another Member State of the European Community or party to the Agreement on the European Economic Area, in which it has obtained a marketing authorisation for the same animals of destination;
' 2 ° Dont the quantitative and qualitative composition in active ingredients and excipients, the pharmaceutical form and the therapeutic effects are identical to those of a veterinary medicinal specialty having obtained authorisation to Market issued by the French Food Safety
. However, under the conditions laid down in c and d of the I of Article R. 5141-123-8, the speciality may contain quantities of active ingredients or different excipients, or excipients of a different nature from those of the specialty having obtained a Marketing authorisation issued by the French Food Safety Agency, since these differences have no therapeutic impact and do not pose a risk to public health.
" Art. R. 5141-123-7. -Except where there are reasons for human health or animal health, parallel import authorization shall be granted if the following conditions are met:
" 1 ° The veterinary medicinal specialty is obtained from an authorised undertaking within the meaning of Article 65 of Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 as amended establishing a Community code relating to Veterinary drugs;
" 2 ° Lots of this specialty have been released in accordance with section 55 of the same directive;
" 3 ° Subject to the provisions of Article R. 5141-123-8, the contents by weight, volume or number of units of catch, the summary of the characteristics of the product, the conditions of prescription, grant and administration, the notice and The labelling of the veterinary medicinal product, as it will be marketed, shall be identical to those of the veterinary medicinal specialty having obtained the marketing authorisation in France
In addition, for reasons of human health or animal health, the Director-General of the French Food Safety Agency may make the authorization to import parallel to a change in the name initially Proposed.
" Art. R. 5141-123-8. -I.-The veterinary medicinal specialty for which the parallel import authorisation is sought may differ from the specialty having obtained the marketing authorisation in France, since these differences do not have any Therapeutic incidence and do not pose a public health risk with respect to:
" (a) The duration of the stability, the special conservation precautions when they are more stringent than those of the veterinary pharmaceutical specialty having obtained market authorization in France;
" (b) Size, shape, colour, engraving, printing or other marking;
" (c) Qualitative or quantitative composition in excipients;
" (d) Quantitative composition in principle active.
" II. -The labelling of the veterinary specialty benefiting from a parallel import authorisation may differ from that of the veterinary medicinal specialty having obtained the marketing authorisation in France, in that it Includes:
" (a) The name and address of the establishment responsible for making the modification of the packaging and of the holder of the parallel import authorization;
" (b) The parallel import authorization number and the marketing authorisation number of the veterinary specialty in the State of origin at the place of the market authorization number in France;
" (c) Special conservation precautions for the veterinary specialty veterinary medicinal product with a parallel import authorisation, where they are more stringent than those of the veterinary medicinal product which has obtained Market authorization in France;
" (d) The size, shape, colour, engraving, printing or other marking of the veterinary medicinal specialty benefiting from a parallel import permit, where they are different from those of the pharmaceutical specialty Veterinarian who obtained market authorization in France.
" III. -The leaflet of the veterinary medicinal specialty benefiting from a parallel import authorisation may differ from that of the veterinary medicinal specialty having obtained the marketing authorisation in France, in that it Includes:
" (a) The name and address of the establishment responsible for making the modification of the packaging, as well as those of the holder of the parallel import authorisation;
" (b) The qualitative or quantitative composition in excipients where it differs from that indicated on the leaflet of the veterinary specialty that obtained market authorization in France;
" (c) The quantitative composition in principle active when it differs from that indicated on the leaflet of the veterinary medicinal product which obtained the marketing authorisation in France;
" (d) Special precautions for the conservation of the veterinary specialty benefiting from a parallel import authorisation where they are more stringent than those of the veterinary medicinal specialty having obtained Market authorization in France.
" Art. R. 5141-123-9. -The request for authorisation for parallel importation of a veterinary medicinal product is addressed to the Director General of the French Food Safety
. It mentions:
" 1 ° The name or name and address of the applicant;
" 2 ° With regard to the veterinary medicinal specialty having obtained the marketing authorisation in France, its name within the meaning of Article R. 5141-1, its pharmaceutical form, its qualitative and quantitative composition in principles Destination animals and assets;
" 3 ° With regard to the veterinary medicinal specialty subject to the request for parallel import authorisation:
" (a) State of origin;
" (b) The name, the content by weight, volume or number of units of taking and the nature of the conditioning of the specialty in the State of origin, as well as the name within the meaning of Article R. 5141-1, the content and nature of the Packaging the specialty as it will be marketed in France;
" (c) The copy of the marketing authorisation granted to it in the State of origin, accompanied, where appropriate, by its translation;
" (d) The pharmaceutical form, the route of administration, the qualitative and quantitative composition in active principles, the animals of destination and, for the specialities to be administered to animals whose flesh or products are For human consumption, the waiting time referred to in the marketing authorisation issued by the State of origin;
" (e) The detailed description of the speciality, including its size, shape, colour, engraving, printing or other marking;
" (f) The name or name and address of the company (s) located in the State of origin from which the applicant has obtained the speciality;
" (g) Where the applicant is aware of the name or name and address of the manufacturer of the specialty;
" (h) If it is separate from the applicant, the name or name and address of the establishment authorised under Article R. 5142-1 or Article 44 of Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 Amending a Community code relating to veterinary medicinal products responsible for the modification of packaging;
' (i) The precise description of the process for modifying the conditioning of the specialty as it will be marketed in France, after obtaining the parallel import authorization;
" (j) If consignments of imported specialities are not stored by the applicant himself or by the establishment which has effected the modification of the packaging, the name or the name and address of the depositary within the meaning of Article R. 4. 5142-1 which will be responsible for storage.
" Art. R. 5141-123-10. -The application for authorisation to import a veterinary medicinal product in parallel shall be accompanied by a file containing:
' (a) For each presentation, a sample of the specialty having obtained the marketing authorisation in France and a sample of the speciality marketed in the State of origin, the importation of which in France is envisaged;
" (b) A copy of the authorisation to open the establishment authorised under Article R. 5142-1 or Article 44 of Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 as amended establishing a Community code Relating to veterinary medicinal products and responsible for making the modification of packaging;
" (c) Packaging and leaflet of the specialty as it will be marketed in France.
" The information or documents established in the foreign language are accompanied by their translation authenticated in French.
" Art. R. 5141-123-11. -The Director-General of the French Food Safety Agency shall notify the person concerned of his decision regarding the proven or potential risk to human or animal health within a time limit from the date of receipt of the request Complete mentioned in R. 5141-123-9:
" (a) Forty-five days for products whose quantitative and qualitative composition in active ingredients and excipients, the pharmaceutical form and the therapeutic effects are identical to those of a veterinary specialty Having obtained a marketing authorisation issued by the French Food Safety Agency;
(b) Ninety days for products which contain quantities of active ingredients or different excipients, or excipients of a different nature from those of the specialty having obtained a marketing authorisation issued by The French Food Safety Agency.
" The time limit for examining the application for authorisation to import a pharmaceutical specialty is suspended, until receipt of the information requested, if the Director-General of the French Food Safety Agency requires The applicant for the additional information which would be necessary for the processing of the application or when the Director-General of the French Food Safety Agency requests additional information from the health authority Competent authority from the speciality.
" The silence maintained by the Director General of the French Food Safety Agency shall be valid for the expiry of the time limits referred to in this
. Art. R. 5141-123-12. -The parallel import authorisation shall be issued for a period of five years. It specifies the differences mentioned in Article R. 5141-123-8 with the specialty having obtained the marketing authorisation in France. It is published in the Official Journal of the French Republic.
" Art. R. 5141-123-13. -I.-In the case of repackaging, the holder of a parallel import authorisation of a veterinary medicinal product warns of the placing on the market in France, during the marketing of that specialty, the holder of Authorisation for placing the speciality on the market in the Member State of origin. It shall provide it, on its request, with a sample of the specialty as it will be placed on the market
II. -At the time of the first marketing, the holder of a parallel import authorisation shall provide a sample of the speciality, as it will be placed on the market, to the French Food Safety Agency, which ensures its Compliance with parallel import authorization.
" Art. R. 5141-123-14. -The request for the renewal of a parallel import authorisation shall be accompanied by a document attesting that no change has occurred in the elements produced by the person concerned in support of his application for an initial authorisation or his The last application for renewal and during the authorization period. The request to renew a parallel import authorization shall be filed no later than three months before the expiry date of the authorization.
" If no decision is notified or if no further request is made to the applicant within three months of receipt of the application, the authorisation shall be considered renewed on the expiry of that
. The renewal of the authorization shall be granted under the conditions set out in R. 5141-123-7 and R. 5141-123-12.
" Art. R. 5141-123-15. -After its grant, the parallel import authorisation shall be suspended or deleted by the Director General of the French Food Safety Agency where the speciality no longer satisfies the conditions of the authorisation.
" Except in cases of urgency, such suspension or cancellation decisions shall only take place after the holder of the authorisation has been given the opportunity to submit his
. Art. R. 5141-123-16. -When the Director-General of the French Food Safety Agency notifies the holder of the authorisation for the parallel importation of a veterinary medicinal specialty an amendment to the authorisation for placing on the Market of the authorised veterinary pharmaceutical specialty in France, this amendment is reproduced by the holder of the parallel import authorisation in the summary of characteristics of the product, the leaflet and the labelling of the specialty Veterinary medicinal products as marketed in France.
" Art. R. 5141-123-17. -The operation, as defined in the second paragraph of Article R. 5142-1 and, in the case of pharmacovigilance, of articles R. 5141-104, R. 5141-105 and R. 5141-108, of a veterinary medicinal specialty benefiting from a Authorisation for parallel importation shall be granted by the holder of that authorisation, provided that he has obtained the opening authorisation provided for in Article L. 5142-2.
' Art. R. 5141-123-18. -As soon as it becomes aware, the holder of a parallel import authorisation of a veterinary medicinal product shall immediately inform the holder of the marketing authorisation in the State of origin of any effect Serious adverse, as defined in section R. 5141-92, concerning the imported specialty.
" It shall also inform the French Food Safety Agency of any changes which it is aware of concerning the marketing authorisation granted to the speciality in the State of
. Art. R. 5141-123-19. -For veterinary medicinal specialities subject to the parallel import authorisation provided for in Article R. 5141-123-12, customs officers shall control the corresponding parallel import authorization number which appears on the Packaging. When the parallel import authorization number is not on the packaging at the time of importation, the copy of the parallel import authorization is presented at the time of the inspection by the customs officers.
" Art. R. 5141-123-20. -The provisions on imports and exports of veterinary medicinal products shall apply:
" 1 ° Drugs classified as narcotic or to which the regulation of narcotic drugs is applied in whole or in part;
" 2 ° to drugs classified as psychotropic.
" These medicinal products, however, remain subject to the special provisions which concern them, respectively, and which are laid down in Articles R. 5132-78, R. 5132-27 and R. 5132-91. "
The Minister of Solidarity, Health and Family Affairs, the Minister of Economy, Finance and Industry, and the Minister of Agriculture, Food, Of the implementation of this Decree, which will be published in the Official Journal of the French Republic.
Done at Paris, 27 May 2005.
Jean-Pierre Raffarin
By the Prime Minister:
The Minister of Solidarity,
Health and Family,
Philippe Douste-Blazy
Minister of Economy,
Finance and Industry,
Thierry Breton
Minister of Agriculture, Food,
Fisheries and Rurality,
Dominique Bussereau
