Communiqué Regarding the Principles of Taking Samples from Veterinary Health Products like Vaccine, Serum, Dilution Liquid and Biological Substance
Referance Law 3285, 6343 CHAPTER ONE Objective, scope, legal basis and definitions Objective Article 1 – The objectives of this Communiqué are to regulate the particulars related to appropriate sampling of the veterinary health products that are used against animal diseases and are produced in Turkey or imported, like vaccine, serum, dilution liquid and biological substance, both during the production phase and after, from the production laboratory or from the entrance customs during importation; and delivery of such samples to the inspecting institutes under appropriate conditions. Scope Article 2 – This Communiqué covers the principles of sampling of substances, which belong to real and legal persons and public institutions and which are used in animal diseases related to veterinary practice, such as all kinds of vaccines and sera; all microorganisms and cell cultures including the ones obtained by hybridoma or recombinant–DNA techniques; products extracted from biological tissues, live agents produced in embryo or animals, probiotics, competitive exclusions, chemical materials not used for medical treatment and diagnosis indicators; the principles of delivering such samples to the related institutions for inspection under proper; and the penalties to be implemented in case of non-compliance with the provisions of this Communiqué during such sampling and delivery. Legal Basis Article 3 – This Communiqué is prepared in accordance with the Law on the Execution of Veterinary Profession and Establishment and Activities of Turkish Veterinarians’ Association and Chamber, no: 6343 dated 9.3.1954, and Regulations on Animal Health and Security dated 8.5.1986 no: 3285. Definitions Article 4 – The terms used in this Communiqué have the following meanings: Ministry: The Ministry of Agriculture and Rural Affairs. General Directorate: General Directorate of Quarantineand Control. Institute: Institutes of Veterinary Control and Research, Manisa Poultry Diseases Research and Vaccine Production Institute, and Foot and Mouth Disease Institute. Provincial Directorate: Provincial Directorates of the Ministry of Agriculture and Rural Affairs. Quarantine and Customs Veterinary Directorate: Quarantine and Customs Veterinary Directorates in Ýstanbul and Ýzmir. Vaccine: Preparations having antigenic materials that establish immunity when given to animals by triggering their immune system. Serum: Preparations that contain specific immunological substances and that are used for both preventive and medical treatment in animals. Dilution liquid: Liquid used to dilute lyophilized vaccines and biological substances. Biological substance: Material of organic origin used in animals for diagnosis, treatment and prevention. Chemicals: Materials formed from chemical elements or produced using chemical methods. Immune modulator: Material increasing or decreasing immune response specifically or non-specifically. Veterinary health products: Substances such as all kinds of vaccines and sera, all microorganisms and cell cultures including the by ones obtained recombinant DNA or hybridoma techniques, products extracted from biological tissues, live agents produced in embryo or animals, probiotics, competitive exclusions, chemicals not used for treatment purposes and diagnostic indicators used in veterinary medicine. Production laboratory: Private laboratories belonging to real and legal persons and laboratories belonging to public institutions and organizations where veterinary health products like vaccine, serum, dilution liquid and biological substance are produced. Company: Institutions belonging to real or legal persons producing or importing veterinary health products like vaccine, serum, dilution liquid and biological substance. Sampling: The operation of taking samples from a lot or batch for control purposes. Unit: Each of the packages forming the lot or batch submitted for control. Lot or batch: The product whose type, length and packing is predefined, which has the same serial number and expiry date, and which is produced at one run. Sample: Product unit of specified quantity, taken completely randomly from various parts of a lot or batch without looking at the quality in order to make the controls of inquired properties. Set: Required number of units that represent the produced or imported lots. CHAPTER TWO APPLICATION AND ESTABLISHMENT OF THE COMMISSION Application Article 5 – In order to be able to conduct inspection of veterinary health products like vaccine, serum, dilution liquid and biological substances, private production laboratories shall apply to the related Provincial Directorate with the petition attached in Annex – 1 of this Communiqué, so that the petition is delivered to the Ministry. Provincial Directorate sends this petition, attached to a letter, to the General Directorate in the quickest way. On the other hand, the producer public institutions and organizations submit their petition given in Annex – 2 of the Communiqué directly to the Ministry. Importers submit their applications to the Quarantine and Customs Veterinary Directorate at the customs entrance of the product; at places where there is no Quarantine and Customs Veterinary Directorate applications are submitted to the Provincial Directorate. Establishment of the Commission Article 6 – Process of sampling Veterinary Health Products like vaccine, serum, dilution liquid and biological substance produced or imported by the producer laboratories belonging to real or legal persons and production laboratories belonging to public institutions or organizations, is done by a commission comprising at least three members. After the applications reach the General Directorate, via Provincial Directorates for production laboratories of real and legal persons and directly for production laboratories of public institutions and organizations; instructions are given by the General Directorate, on taking of samples by a commission. For sampling of the imported veterinary health products, instructions are given to the commission to take samples during the approval of the control documents. The commission formed by the General Directorate for private production laboratories consists of the related institute, Provincial Directorate and the responsible veterinarian from the company. The commission formed for the public institutions and organizations consists of selected veterinarians nominated by the institute or institutes determined by the Ministry. The commission formed for taking samples from imported veterinary health products consists of the responsible veterinarians of Quarantine and Customs Veterinary Directorate, Provincial Directorate and the Company. At places where there is no Quarantine and Customs Veterinary Directorate, commission consists of two veterinarians from Provincial Directorate and the responsible veterinarian of the company. Participation to the Commission from General Directorate and other institutes is also provided if deemed necessary by the Ministry. CHAPTER THREE Number of Samples, Sampling, Sampling Minutes, and Preparation of Sample Labels Number of Samples Article 7 – The number of samples to be taken from the veterinary health products, produced by the private production laboratories or in the production laboratories of public institutions or organizations, or, desired to be imported is determined by the Ministry in a published instruction. These numbers can be amended by the Ministry in case of necessity. Sampling Article 8 - The commission takes a set of samples in their original package such that it represents a series wholly from the products produced or desired to be imported. The bottle and dosage quantities of the necessary products existing in every set are determined by the instructions published by the Ministry. In case there exists unpacked, unlabelled labels or labels where some of the information is missing or incomplete series, the case is recorded in a minutes and no sample is taken. If the samples are taken from private production laboratories or from the production laboratories belonging to public institutions or organizations, one set of sample is left to the producer private production laboratory or public institutions and organizations. Two sets are sent to the related institute who shall do the control. If samples are taken from the samples imported a set of samples is left to the importing company. A set is sent to the Quarantine and Customs Veterinary Directorate, if there is no such a place, to the Provincial Directorate. The other two sets are sent to the institute who shall do the control. One of the sets sent to the institute is used for control the other is left as a testifying sample. The testifying samples left in the institute are kept until three months after the expiry date. Commission or the institute doing the control may take samples from the vaccine, serum, and dilution liquid or biological material during any stage of production, from final product, from the product on sale or stocks in the producer's stores, taking permission of the Ministry or upon instructions of the Ministry. Sampling Minutes and Preparation of Sample Label Article 9 - A sample label and the sampling minutes enclosed to this Communiqué is prepared separately for each set of sample taken. Samples of veterinary health products like vaccine, serum, dilution liquid and biological material are packed according to their specifications without giving any harm. Sample label is attached, fixed with lead and stamped to each set taken. If the sample is taken from a production laboratory belonging to private or public institutions and organizations, sampling minutes in Annex - 3 and sample label in Annex - 4 of the Communiqué are prepared. One set of sampling minutes and sample labels prepared in three copies is given to the production laboratory belonging to private or public institutions and organizations; remaining two sets are sent to the institute doing the control together with the samples. If the sample is taken from an imported product sampling minutes in Annex - 5 and sample label in Annex - 6 of the Communiqué are prepared. One set of sampling minutes and sample labels prepared in four copies is given to the importing company, one set remains with the related Quarantine and Customs Veterinary Directorate, remaining two sets are sent to the institute doing the control together with the samples. CHAPTER FOUR Protection and Storage of the Samples, Sending the Samples and Conducting Sample Analyses Protection and Storage of the Samples Article 10 – The samples taken are stored at the conditions specified on their labels. Control samples shall be maintained until 3 months after the expiry date of the product. Samples older than such date are destroyed at the Institutes in accordance with the related principles. Sending the Samples Article 11 – The samples taken are delivered to the related Institute in the quickest way possible, under the supervision of the Commission and in compliance with the related principles and rules of cold chain, the costs borne by the company. Conducting Sample Analyses Article 12 – The related Institutes that are appointed by the Ministry and that take the samples of veterinary health products such as vaccines, sera, dilution liquid and biological substance, shall conduct the sterility, harmfulness and if deemed necessary by the Ministry, immunity analysis in the shortest time possible, the costs borne by the company. CHAPTER FIVE Penalty Provisions and Final Provisions Penalty provisions Article 13 – The private producer laboratories or the laboratories belonging to public institutions and organizations shall have the veterinary health products they produce in accordance with the production permit issued by the Ministry controlled by the Institute appointed by the Ministry before they introduce such products into the market. Likewise, the importer companies shall have the veterinary health products they import in accordance with the importation permit issued by the Ministry controlled by the Institute appointed by the Ministry before they introduce such products into the market. In case the provisions of this Communiqué are not complied with during sampling or delivery to the Institute, the related provisions of the Law on Animal Health Security, No. 3285 are implemented. Enforcement Article 14 – This Communiqué enters into force on its publishing date. Execution Article 15 – The provisions of this Communiqué are executed by the Ministry of Agriculture and Rural Affairs. ANNEX - 1
To the ......................... Provincial Directorate of
I submit to you for doing the necessary on the subject of taking the samples and sending it to the related institute for the control of our veterinary health product in .......... doses, ..........bottles produced in our company under trade name ............... with serial no: ............ having an expiry date .........
ANNEX - 2
To the General Directorate of Quarantine and Control of
I submit to you for doing the necessary on the subject of taking the samples and sending it to the related institute for the control of our veterinary health product in .......... doses, ..........bottles produced in our company under trade name ............... with serial no: ............ having an expiry date .........
ANNEX –3 SAMPLING MINUTES
We declare that in accordance with the Communiqué Regarding the Principles of Taking Samples from Veterinary Health Products like Vaccine, Serum, Dilution Liquid and Biological Substance, three set of samples were taken. One set was left to the private production laboratory or public institutions and organization doing the production, the other two were sent to the institute selected by the Ministry for doing the necessary controls; the labels put on samples were signed and stamped and this minute was prepared by us.
- If the sample is taken from a company, a veterinarian from the Animal Health Directorate of Provincial Directorate shall attend the subject commission. ANNEX - 4 SAMPLE LABEL
- If the sample is taken from a company, a veterinarian from the Animal Health Directorate of Provincial Directorate shall attend the subject commission. ANNEX - 5 SAMPLING MINUTES
We declare that in accordance with the Communiqué on Sampling Rules from the Veterinary Health Products like Vaccine, Serum, Dilution Fluid and Biological Material four set of samples were taken. One set was left to the company doing the importation. One set was given to Quarantine and Customs Veterinary Directorate. The other two were sent to the institute selected by the Ministry for doing the necessary controls. The labels put on samples were signed and stamped and this Communiqué was prepared by us.
ANNEX - 6 SAMPLE LABEL
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