Q4/2017 Pharmaceuticals, Healthcare & Biotechnology
The Recall Regulation has been published in the Official Gazette dated November 19, 2015 and numbered 29537 (“The Regulation”). This Regulation has abolished the former regulation (published in the Official Gazette dated August 15, 1986 and numbered 19196). Pursuant to the amendments, the authority which is entitled to make the recall decisions has been determined as Pharmaceuticals and Medical Devices Agency of Turkey.
The scope of the Regulation has been expanded. The former regulation has covered only the fault products but the new regulation also includes the products that are suspected to be fault.
Recall regime has been re-organized as per the Regulation. The liable firm shall fill a form about the relevant products that is provided by the Authority and submit it to the authority in 5 days as of the date of recall decision.
The liabilities;To inform the distributor or country’s authority in case of the product has been exported To inform the Authority about the content and reason of the recall for the serials of the products whereof the products are licensed in Turkey in case of a retraction in a foreign country
have been included.
The liability period for the liable firm on keeping relevant information and records in respect of the recall has been extended from 1 year to 5 years.
The period for the liable firm on bringing the fault products under control following the recall has been shorten from 3 days to 2 days for 2nd class recalls and 6 days to 3 days for 3rd class recalls.
The limited period determined for the compensation of damages by the liable firm has been removed.
The Regulation on Sale, Advertisement and Promotion of Medical Devices (published in the Official Gazette dated May 15, 2014 and numbered 29001) (the “Regulation” ) was published by the Turkish Pharmaceutical and Medical Device Institution. The Regulation sets out procedures and principles for the sale, advertisement and promotion of medical devices by sales centres which are distributing and selling such devices. Individuals and legal entities which do not comply with the provisions of this Regulation shall not be entitled to sell medical devices. Pursuant to Article 5 of the Regulation, individuals and legal entities sales centres shall apply to relevant provincial directorates of health in order to obtain authorization to carry out sales activities. Following the application, the relevant provincial directorate of health shall evaluate the application and give the authorization certificate if the applicant complies with requirements stated under the Regulation.
The Regulation on Pharmaceutical Safety (published in the Official Gazette dated April 15, 2014 and numbered 28973) was published by the Turkish Pharmaceutical and Medical Device Institution (the “Regulation”). The Regulation introduces contractual pharmacovigilance service institutions to carry out all pharmacovigilance activities which were carried out only by license holders before. Accordingly, such contractual institutions, which shall be subject to the approval and audit of Turkish Pharmaceutical and Medical Device Institution, can be outsourced by license holders to carry out activities in relation to safety of pharmaceutical products. Other provisions of the Regulation are almost the same as the Regulation on Monitoring and Evaluation of the Safety of Medicinal Products for Human Use (published in the Official Gazette dated March 22, 2005 and numbered25763), which was abolished by virtue of Article 35 of the Regulation.
Amendment on Biocidal Products Regulation was published in the Official Gazette dated March 12, 2014 and numbered 28939.
Health services license has been abolished as per the Article 7 of the Law Regarding the Amendment of Decree Law Concerning the Organization and Duties of the Ministry of Health and other Several Laws (published in the Official Gazette dated January 18, 2014 and numbered 28886) (Law No: 6514) (the “Law”) since the sub paragraph two of the Article 57 of the Statutory Decree Concerning the Organization and Duties of the Ministry of Health (published in the Official Gazette dated November 2, 2011 and numbered re. 28103) has been repealed by the Law. Furthermore, Regulation on Health Services License (published in the Official Gazette dated November 30, 2012 and numbered 28483) has been abolished by the Regulation Regarding the Abolishment of the Regulation on Health Services License (published in the Official Gazette dated February 20, 2014 and numbered 28919). As per the repealed regulation, individuals and legal entities were required to obtain license from the Ministry of Health (“Ministry”) in order to provide health services or open health facilities. The requirement to obtain a license was abolished by the Ministry in order to reduce the additional costs of new health investments since the investors are also required to obtain permission from the Ministry.
The Communiqué on Support the Payment of the Fight against Vegetable Production of Biological and/or Bioengineering was published on August, 10 2012. The aim of the Communiqué was to provide alternative techniques to chemical control in crop production, to reduce the use of chemical drugs in order to protect human health and natural balance of open field tomatoes, citrus fruits, apples, vineyards and greenhouse vegetable production, biological, and / or biotechnical
The Pharmacist and Pharmacies Law and Narcotic Drug Control Law (published in the Official Gazette on December 18, 1953 numbered 6197) was amended on May 17, 2012 (as announced in the Official Gazette May 31, 2012) to widen the procedures and principles for opening a pharmacy.
The Regulation on Private Hospitals (published in the Official Gazette dated March 27, 2002 and numbered 24708) was amended by the Ministry of Health on May 27, 2012 to include Foundation Universities with the main features considered on a broad basis.
The Communiqué Regarding the Implementation of Principles and Procedures for Intensive Care Unit Services in Health Facilities with Beds (published in the Official Gazette dated July 20, 2011 and numbered 28000) was amended on February 18, 2012. Such amendment includes changes with respect to the minimum bed and space requirements in intensive care units as well as room qualifications.