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RE: Importation from outside the EU
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Dear Andrew I cannot agree with Alan Newberry's advice and in such circumstances, where there is a conflict in experience, it is my advice that we should seek guidance from the EMEA. The following is taken
from the EMEA website:18. What batch release arrangements in the EEA are required for my medicinal product?Importing site/Supervisory Authority:According to Article 51(1) of Directive 2001/83/EC as amended, each batch of a medicinal product must be certified by a Qualified Person prior to be released for market in the EEA. In the case of products imported from a third country, and for the purpose of Article 51(1)(b) of Directive 2001/83/EC as amended, the site where the certification of batches by the Qualified person occurs, is considered to be the importing site in the EEA (and not necessarily the site through which the batch first physically enters the EEA). There should only be one importing site in the EEA. If an applicant of a marketing an Authorisation requires a product to be imported and batch release carried out at more than one site in the EEA, a full justification based on technical and/or public health grounds must be provided. In accordance with the provisions of Article 18 of Regulation (EC) No 726/2004 the Supervisory Authority(ies) shall be the competent authorities of the Member State or Member States which granted the manufacturing authorisation provided for in article 40(1) of Directive 2001/83/EC as amended in respect of the manufacture of the medicinal product. In the case of products imported from third countries, the Supervisory Authority(ies) shall be the competent authority(ies) of the Member State(s) which granted the manufacturing authorisation provided in Article 40(3) of Directive 2001/83/EC as amended to the importer, unless a Mutual Recognition Agreement (MRA) covering GMP for the product under consideration is operating with the country where the medicinal product is manufactured. Batch testing upon importation: For medicinal products imported from third countries, retesting of each batch within the EEA upon importation is required unless a Mutual Recognition Agreement (MRA) covering GMP for the product under consideration is operating with the country where the medicinal product is manufactured. If such MRA is in operation, batch controls/tests carried-out in the country where the product is manufactured are acceptable. It should be noted that MRAs cover batch control/testing and do not cover batch release. Batch release must take place in the EEA territory for every production batch released to market in the EEA, regardless of if a MRA with the exporting country is in place or not. Therefore, the batch release of an imported medicinal product from a third country without re-testing is a serious failure of a qualified person's legal obligations. According to Article 52 of Directive 2001/83/EC as amended, it is expected that Member States' Supervisory Authorities to launch appropriate administrative measures towards such a qualified person and withdraw the product concerned from the market (Article 117(1)(e) of Directive 2001/83/EC, as amended). Contracting out of certain controls: The provisions of Article 20(b) of Directive 2001/83/EC as amended allows certain of the controls required under the provisions of Article 51(1) of Directive 2001/83/EC as amended, to be contracted out to third parties, if justified, and provided that the laboratories have been verified by the Competent Authorities. Laboratories used for contract testing upon importation of medicinal products manufactured in third countries may be located in any EEA country. The Qualified Person of the Manufacturing Authorisation Holder named in the Application is however responsible for ensuring that any contract laboratory used carries out the controls in accordance with Good Control Laboratory Practice and Good Manufacturing Practice, as applicable and with the requirements of the Marketing Authorisation once granted. References
I believe this provides you with the best advice: the highlighting is my own. Alan Longworth -----Original Message----- From: gmp@www2.pharmweb.net [ mailto:gmp@www2.pharmweb.net] On Behalf Of Newbery, Alan Sent: 08 January 2010 18:20 To: GMP Forum Subject: RE: Importation from outside the EU Andrew My understanding is that the product has to be tested in the importing country. Only in exceptional circumstances is testing in another country permitted. A couple of years ago one of my clients imported into Northern Ireland and wished to perform 1 test in the Republic of Ireland - the test lab was only 20 miles away. This was refused and the test had to be carried out in the South of England - several hundred miles away. Among many other things you should also need to consider which QP will be responsible for auditing the manufacturer and which QP will handle Complaints and Recalls. Which address will be on the PIL etc? You seem to have 2 choices 1) Let the testing company be the importer and after release transfer the stocks to your company so that you can distribute. 2) Transfer the analytical testing to your company. Alan Newbery The GMP Discussion Group is sponsored by gmp review - see http://www.pharmweb.net/gmp.html No virus found in this incoming message. Checked by AVG - www.avg.com Version: 9.0.725 / Virus Database: 270.14.129/2606 - Release Date: 01/08/10 07:35:00 |
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