T.C.
GIDA, TARIM ve HAYVANCILIK BAKANLIĞI
Gıda ve Kontrol Genel Müdürlüğü
Communiqué on the Principles to be adopted in the Importation of Veterinary Biological Products
Referance Law 3285, 6343
National Press 09.07.2002-24810
Communiqué No 2002-37
CHAPTER ONE
Objective, Scope, Legal Basis and Definitions
Objective
Article 1- This communiqué has been prepared in order to enable the utilization of the veterinary biological products for the animal health in a more efficient and productive way by determining the health and technical requirements to be adopted in the importation, storage and protection of these products used against the animal diseases.
Scope
Article 2- This Communiqué both covers the required procedures to be adopted in the importation of veterinary biological products to be imported by the real and legal persons and public institutions and corporations and the procedures to be applied in case of non-compliance with the provisions of this Communiqué.
Veterinary biological products which will be imported to be used in the researches conducted within the framework of the Ministry permission are excluded from the scope of this Communiqué.
Legal Basis
Article 3- This Communiqué has been released in accordance with the Legislation on the Execution of The Profession of Veterinarians, the Formation Procedures and the Activities and Responsibilities of the Turkish Veterinarian Associations dated 9/3/1954 and numbered 6343, the Legislation on the Animal Health and Sanitation dated 8/5/1986 and numbered 3285 and also the Decree in Law on the Establishment and Duties of the Ministry of Agriculture and Rural Affairs dated 7/8/1991 and numbered 441.
Definitions
Article 4- The terms used in this Communiqué are as follows:
Ministry: The Ministry of Agriculture and Rural Affairs
General Directorate: The General Directorate of Protection and Control
Provisional Directorate: The Provincial Directorates of the Ministry of Agriculture and Rural Affairs
Directorate of Institute: Veterinary Control and Research Institutes, Foot and Mouth Disease (FMA) Institute Chicken Disease Research and Vaccine Production Institute.
Veterinary Biological Products: Substances such as all kind of vaccines and serums used in veterinarian medicine; all cultivating microorganisms and cells cultures including the ones obtained by using the recombinant – DNA or hibridoma techniques, the products obtained by the biological tissues; viable agents produced in animals or embryos, probiotics, competitive exclusions and diagnostic spectrums
Vaccine: The agents which enable immunity through the antigenic substances they contain by stimulating the immunity system of the animals to which they are implanted.
Serum: The agents containing specific immunity substances and used for the protection and treatment of the animals.
Diluting Liquid: The liquid used in the dilution of liyofilize vaccine and biological substances.
Biological Substance: Substances organic origin used to diagnose, treat and protect animals.
Immunity Modulator: The substances increasing or reducing the immunity response specifically or non-specifically.
Firm: The real and legal persons importing veterinary biological products such as vaccine, serum, diluting liquid and biological substance.
Control certificate: The certificate confirmed by the Directorate General during the actual importation of the substances to be imported within the framework of the Decision on the Technical Regulations and Standardization Regime in Foreign Trade and within the scope of the related Communiqué.
CHAPTER TWO
Application Principles For the Products to be Imported
Application Principles For the Products to be Imported For the First Time
Article 5- The real and legal persons as well as public institutions and corporations apply to the Directorate General with a petition for the veterinary biological products to be imported for the first time after they complete the following information and documents. They must attach the following documents to their petitions.
a. Trade Registration Paper
b. Free Sale Document containing the information whether the product to be imported is used in the country of origin and taken from the authorized official bodies
c. The document demonstrating in which countries the product to be imported is sold or licensed.
d. The certificates taken from the authorized official body regarding the authorization and control system of the producer laboratory in the country of origin and their confirmed translations to Turkish.
e. The original prospectus and label of the veterinary biological products to be imported for the first time and their translations to Turkish.
f. The original and the translated copy of Production and Control Protocol
The production and control protocols of biological products are not returned after having been applied to the Ministry.
When seen necessary by the Ministry, the real and legal persons as well as public institutions and corporations may be obliged to resubmit importation and production certificate and production and control protocol.
Principles to be Required in the Production and Control Protocol
Article 6- The following factors are taken into consideration during the investigation of the production and control protocols of the veterinary biological products to be imported.
1. The antigenical compliance of the suş used in the production of the biological products to be imported with the suş causing diseases in our country.
2. The existence of the publications and documents obtained from the scientific institutions about the suş used in the production of the biological products to be imported .
3. The documentation of the production standards demonstrating that the production is made in accordance with one of the international production standards (Good Manufactory Practice (GMP), European Pharmacopoeia, Code of Federal Regulations (9CFR), Manual of Standards for Diagnostic Tests and Vaccines (OIE), etc...) In case this can not be provided, then the documentation demonstrating that the production laboratories are licensed and controlled by the competent authorities of the home country.
4. The other details which will be required for the production and control protocol of biological product to be imported are determined by the Ministry.
The Directorate General does not allow the importation of a product constituting a risk for the country by making risk analysis in compliance with the International Epidemic Office Code for the veterinary biological product to be imported.
Application Principles for the Actual Importation
Article 7- The importers- real and legal persons as well as public institutions and corporations- will apply to the Ministry for the actual importation of the veterinary biological product with the following information and documents.
a. Control certificate,
b. Proforma invoice(the serial number, expiry date, packing style and the amount of the products will be stated),
c. The confirmed analysis certificate demonstrating that quality controls of each series of the product concerned have been made. (for vaccines; the documents demonstrating that the vaccine series concerned is sterile, harmless and efficient.),
d. The original prospectus and label of the veterinary biological product to be imported and their translations to Turkish,
e. The working contract or document concluded by the importers- real and legal persons as well as public institutions and corporations- with the Veterinarian responsible from the products,
f. Credibility document for the stocking place of the veterinary biological product,
g. The points regarding the information and documents stated in the items (d), (e) and (f).
CHAPTER THREE
Control Principles and Other Provisions
Quality Control Principles to be Required for the Product to be Imported
Article 8 – The quality controls of the veterinary biological products arriving at the customs office for the actual importation purposes will be made in accordance with the principles stated as follows:
a) After the required physical controls of the veterinary biological products brought to the customs office chosen by the Ministry are done by the Customs Veterinarians in the places that will be arranged by the customs office, a sample will be taken from the original package in a way which will completely represent the each series of the product by the Commission to be established. The sample taken will be delivered to the related Institute Directorate by the Commission for the realization of sterility, security and when necessary immunity tests.
b)The distribution, sale and use of veterinary biological product will not be realized until the quality control results are obtained.
c) The name, serial number, production date, expiry date and the producer laboratory as well as name and address of the importer must be written on the labels of imported veterinary biological product.
Laboratory Control
Article 9- The Institutes chosen by the Ministry do sterility, safety controls
of the samples of veterinary biological product to be imported in exchange for money as soon as possible. The results are notified to real and legal persons as well as public institutions and corporations concerned, Provincial Directorate, Directorate General in a very rapid way. The sale of products are permitted on the conditions that results are positive. In case of any objection to the control results, control is repeated once more in the institute chosen by the Ministry. The outcome is certain.
The quality control examination fees will be deposited to the revolving fund of Institute Directorate concerned that carried out the examination by importer- real and legal persons as well as public institutions and corporations.
The real and legal persons as well as public institutions and corporations return the imported veterinary biological product found to be negative to the origin. If this can not be realized, then the product is annihilated by way of return of the minutes through the commission to be established by the Customs Offices and in which also a personnel appointed by the firm concern will take place. The annihilation procedure will be carried out by the nearest Institute Directorate and the costs will be covered by the importer.
When seen necessary by the Ministry, veterinary biological products are subject
to the immunity tests on the condition that the costs will be covered by the importer.
When necessary, quality controls are made by the Ministry once again by taking samples from the veterinary biological products supplied to the markets for sale.
The Storage of the Imported Products
Article 10- The importer- the real and legal persons as well as public institutions
and corporations- must provide a cold-storage depot or a storage place that will be specifically used for the storing and protection of the imported veterinary biological products. These depots will be controlled by the Institutes connected to the province concerned and a Credibility Certificate will be taken.
The depots concerned will be inspected by the Ministry or the Institutes at least
once a year or any time when seen necessary. The Credibility Certificates given for the places will be annulled in case these places are found to be inappropriate in the inspections carried out.
The Principles to be Required During the Distribution and Application
of the Products
Article 11- The distribution and application principles of the imported veterinarian biological products are stated as follows:
a. The importation permission must be taken from the Directorate General for the products that will be brought to the country from abroad.
b. The entry of the product to the country and its sale are forbidden unless importation permission is taken.
c. The sale of the products not having prospectus and label in the market is forbidden.
d. The importer real and legal persons must employ a responsible Veterinarian.
e. The importer firms will write the date and the number of the permission taken from the Ministry on the outer package of the products.
f. The importer real and legal persons as well as public institutions and corporations must write the name, amount, serial number and expiry date of the product on the invoice for the veterinary biological products they distribute.
g. During the transportation process of the veterinary biological products, including their importation and delivery to the final sale destination, the importer real and legal persons as well as public institutions and corporations will comply with the cold chain rules for the products other than the ones having specific characteristics (heat resistant).
h. The products excluding the ones having specific characteristics (heat resistant) will be sold in isothermal packages.
i. The importer real and legal persons as well as public institutions and corporations will sell the veterinary biological products only to the institutions employing Veterinarians and/or Veterinarian.
j. The field applications of the veterinary biological products will only be made by the Veterinarians or Veterinarian Health Technicians.
k. The importer real and legal persons as well as public institutions and corporations will send the form attached to the Communiqué which will include information demonstrating the provinces, towns, persons and farms to which they make the importation as well as the name, amount, serial number, expiry date of the veterinary biological products imported.
l. The importer firms must require the real and legal persons they assigned to act as intermediaries for marketing the products that they imported to provide a cold-storage depot in order not to spoil the cold chain of the product concerned.
m. Free lance Veterinarians must record the information and statistics regarding the veterinary biological products they used and also notify the Directorate about these records regularly as required by the Provincial Directorate of the Province where they are engaged in activities.
The Control Principles of Products in Provinces
Article 12- The Provincial Directorates of the Ministry make control in order to determine whether the veterinary biological products imported and supplied to the markets for sale have the characteristics claimed in their prospectus and whether the product concerned has an importation license. The final salesmen and the users failing to store the veterinary biological products in appropriate conditions are subject to criminal procedures stated in the Communiqué.
When seen necessary, a sample is taken from the veterinary biological products imported and supplied to the markets for sale and sent to the competent Institute for control.
The products which have positive sterility and safety results but negative immunity results are collected from the depots and the market and annihilated by the Provincial Directorate.
Advertisement, Introduction and Guidance
Article 13- The importer real and legal persons as well as public institutions and corporations can not behave in a way that will arouse panic, mislead, and deceive the consumer for the product they imported.
However, they can only prepare scientific data and information on animal diseases that are related to the product.
They must comply with the points explained above and take permission from the Directorate General for any kind of activities such as advertisement, introduction and guidance.
Abrogated Legislation
Article 14- “The Communiqué Concerning the Modification of the Communiqué on the Principles to be Adopted During the Importation of Some Veterinary Biological Products” (Communiqué No: 1998/17) published on the Official Gazette dated 29/7/1998 and numbered 23417 and “The Communiqué on the Principles to be Adopted During the Importation of Some Veterinary Biological Products” (Communiqué No: 1998/3) dated 26/2/1998 and numbered 23270 are abrogated with the coming into enforcement of this Communiqué.
Criminal Procedures
Article 15- The ones failing to comply with the principals and essentials stated in the Communiqué and the ones behaving in contradiction with the prohibitions are subject to the Articles 52, 53 and 54 of the “Legislation on the Animal Health and Sanitation” numbered 3285 and also to the related articles of the Regulation published pursuant to this Law and to the provisions of the related Law and Regulation in terms of criminal and legal responsibilities.
The Preparation of the Instructions
Article 16- This Communiqué and instruction on related issues are prepared by the Directorate General.
Enforcement
Article 17- This Communiqué enters into force 30 days after its publication.
Execution
Article 18- The provisions of this Communiqué are executed by the Minister of Agriculture and Rural Affairs.
DISTRIBUTION LIST OF THE VETERINARY BIOLOGICAL
PRODUCTS IMPORTED
Veterinary of the Company Responsible of the company
DISTRIBUTION LIST OF THE VETERINARY BIOLOGICAL
PRODUCTS IMPORTED
| PRODUCT’S | CONTROL CERTIFICATE’S | NAME OF DELIVERED PERSON OR INSTITUTION | ||||
| NAME | SERIAL-NO | EXPIRY | AMOUNT | DATE | NUMBER | OPEN ADDRESS AND TEL.NO SHOULD BE INDICATED |
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Veterinary of the Company Responsible of the company