Des entrepreneurs au service des entrepreneurs are of an occasional nature, exclusively for the personal use of travelers or their families. Goods should not be of a nature or quantity to indicate that they are being imported for commercial reasons. In order to ensure the correct application of the traditional hunting and management of marine resource exceptions, the release for free circulation of the seal product is subject to the presentation of an attesting document issued by a recognized body. Seal products acquired on site in a third country by travelers and imported by them at a later date, must be accompanied by a written notification of import and a document giving evidence where the products were acquired.
Legislation Council Directive 83/129/EEC of 28/03/1983 concerning the importation into Member States of skins of certain seal pups and products derived therefrom (OJ L91 09/04/1983) Regulation (EC) No 1007/2009 of the European Parliament and of the Council of 16 September 2009 on trade in seal products (OJ L-286 31/10/2009) Commission Regulation (EU) No 737/2010 of 10 August 2010 laying down detailed rules for the implementation of Regulation (EC) No 1007/2009 of the European Parliament and of the Council on trade in seal products (OJ L-216 17/08/2010).
2.3.1.4.
Import requirements for medicinal active substances
Active substances intended to be used as raw materials in the manufacture of medicinal products can only be imported by registered authorized operators in the importing Member State. In order to be authorized, operators must meet at least the following requirements:
specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled; have at their disposal suitable and sufficient premises, technical equipment and control facilities as regards both control and storage of these products; have at their disposal the services of at least one qualified person in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.
Active substances may only be imported provided they fulfill certain conditions: have been manufactured in accordance with standards of good manufacturing practice; are accompanied by a written confirmation from the competent authority of the exporting third country ensuring that the legislative provisions applicable to the manufacturing of active substances intended for export to the Union, as well as inspections of facilities and enforcement of the applicable provisions, provide for a level of protection of public health equivalent to that provided for by Union law. The written confirmation shall not be required if the exporting country is included in the list set out in Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (OJ L-325 23/11/2012). Legislation Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L-311 28/11/2001) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L-311 28/11/2001) Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1
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