T.C.
TARIM ve KÖYİŞLERİ BAKANLIĞI
Koruma ve Kontrol Genel Müdürlüğü
Regulation On Private Veterinary Laboratories
Referance Law 3285, 6343, 441
Official Gazette 19.09.1999-23821
CHAPTER ONE
Objective, Scope, Legal Basis and Definitions
Objective
Article 1 - The objective of this Regulation is to regulate the issuance of establishment, opening, work and operation permits of Private Veterinary Diagnostics and Analysis Laboratories and Veterinary Health Products Private Production Laboratories, the control of such establishments and licensing the products produced.
Scope
Article 2 - This Regulation covers the operations to be followed during establishment, opening, work or operation permits, technical and hygienic conditions of the Veterinary Diagnostics and Analysis Private Laboratories, which make analyses and diagnostics about diseases related to veterinary sciences for real and legal persons, and government institutions and organisations; and of the Veterinary Health Products Private Production Laboratories producing vaccines and sera produced on live or lifeless nutrient media, to be used by veterinarians for animal diseases, all kinds of microorganism cultures to be used by veterinarians except the ones obtained using r-DNA techniques, all microorganism and cell cultures to be used by veterinarians including the ones obtained using recombinant DNA or hibridoma techniques, products extracted from biological tissues to be used by veterinarians, live agents produced in embryos or animals, probiotics, competitive exclusions, chemicals not to be used for curing purposes, and diagnostic reagents; and the procedures to be followed if the provisions of this Regulation is not complied with.
Legal Basis
Article 3 - This Regulation is prepared based on the Articles 2, 21, 52, 53 and 54 of Animal Health Security Law, Law about the Execution of the Veterinary Profession, Formation and Functioning of the Turkish Veterinarians Union and Chambers dated 9.3.1954 no: 6343, and Articles 2 and 10 of the Decree Law about Establishment and Duties of the Ministry of Agriculture and Rural Affairs, dated 9.8.1991 no: 441.
Definitions
Article 4 - The terms used in this Regulation are explained below.
Ministry: Ministry of Agriculture and Rural Affairs,
General Directorate: General Directorate of Protection and Control,
Institute: Veterinary Control and Research Institutes to which the province where the laboratory is attached to, Manisa Poultry Diseases and Vaccine Production Institute Directorate and Foot and Mouth Disease Institute Directorate.
Province Directorate: Province Directorates of the Ministry of Agriculture and Rural Affairs.
Veterinary Diagnosis and Analysis Private Laboratory: Laboratories doing the analysis and diagnostics of animal diseases determined by the Ministry, opened by the real persons, legal entities, government institutions and organizations in accordance with the rules of this Regulation.
Products and productions Veterinary Health Private Laboratory: Laboratories producing veterinary health products related to animal diseases and permitted by the Ministry, opened by the real persons, legal entities, government institutions and organizations in accordance with the provisions of this Regulation.
Laboratory Unit: Separate sections that need to exist in the laboratories doing analysis and diagnostics of the animal diseases and laboratories producing veterinary health products used for various animal diseases.
Responsible Laboratory Director: The veterinarian responsible from the operation and management of the laboratories doing analysis and diagnostics of animal diseases and laboratories producing veterinary health products used for various animal diseases.
Laboratory Specialist: Veterinarians who have specialized in their profession or made an academic carrier and who shall work in the laboratories doing analysis and diagnostics of the animal diseases and laboratories producing veterinary health products used for various animal diseases.
Veterinarians: Veterinarians working in the laboratories doing the analysis and diagnosis of the animal diseases and laboratories producing veterinary health products.
Laboratory Technical Personnel: Chemists, biologists, veterinary health technicians and laboratory technicians working in the laboratories doing the analysis and diagnose of the animal diseases and producing veterinary health products.
Veterinary Health Products: Vaccines and serums produced on live or lifeless nutrient media aimed to be used by veterinarians for animal diseases, all kinds of microorganism cultures to be used by veterinarians except the ones obtained using r-DNA techniques, all microorganism and cell cultures to be used by veterinarians including the ones obtained using recombinant DNA or hibridoma techniques, products to be used by veterinarians and extracted from biological tissues, live agents produced in embryos or animals, probiotics, competitive exclusions, chemicals not to be used for treatment purposes, and diagnostic reagents.
Permit of Establishment: The document showing the permission given by the Ministry to establish laboratories doing analysis and diagnostics of animal diseases and producing veterinary health products if their site, projects and drawings are found suitable.
Work Permit: Document showing the work permission given by the Ministry for laboratories, which conduct analysis and diagnostics of animal diseases, which had the permit of establishment given by the Ministry and which were installed in appropriate locations and in accordance with appropriate projects and diagrams.
Operation Permit: Document showing the permission given by the Ministry to operate laboratories which produce veterinary health products to be used for animal diseases and which had the permit of establishment given by the Ministry and which were installed in appropriate locations and in accordance with appropriate projects and diagrams.
Production Permit: Document showing the production permission given by the Ministry to the laboratories to produce the veterinary health products approved by the Ministry who already had their operation permits.
Sales Permit: Document showing the permission given by the Ministry to the laboratories to present their products for sale after found suitable by the Ministry as a result of the harmlessness, sterility and immunity controls done in the laboratories assigned by the Ministry from the samples of produced veterinary health products, which have been given production permits, samples being taken by a commission assigned by the Ministry.
GLP: The quality assurance that the place where the production or diagnosis is to be done is a laboratory medium which has sufficient equipment and personnel.
GMP: Good Manufacturing Procedures: The quality assurance that determines the quality standards of the production site producing the products as it is found necessary in the product specifications or the information forming the base of production permit and according to the standards and aimed usage of products and assuring control.
CHAPTER TWO
Establishment, Work and Operation Permits
Establishment Permit
Article 5 - The persons, legal entities, government institutions or organizations wishing to establish laboratories doing analysis and diagnosis related to veterinarians or producing veterinary health products should apply in petition to the Ministry completing the following information and documents.
a) The statement filled by the owner of the laboratory in accordance with Annex - 1 of this Regulation.
b) Three Plot plans scaled either 1/500 or 1/1000 prepared taking the approval of related construction organization indicating the location of the laboratory and including information about the site and the environment.
c) Three project drawings showing all sections of the laboratory prepared in detail and according to the technical rules.
These documents to be given to the Ministry by the owner of the laboratory are sent to the related institute in order to take their point of view on suitability after being inspected by the Ministry.
Permit of establishment is given to the laboratories found suitable by the Ministry. Permit of Establishment is valid for one year. An additional period is granted to the persons or legal entities that could not complete their laboratories in the given time by the Ministry if it is found suitable. The related governor is informed in writing of the given establishment permits and period extension. Applications should be answered within one month by the Ministry.
Work or Operation Permits
Article 6 - The persons, legal entities, government institutions and organizations who had taken establishment permits and completed their laboratories in accordance with the approved projects and plans are obliged to apply to the Ministry by a petition including the following information and documents in order to get work and/or operation permits.
a) Contract signed with the approval of the notary with responsible laboratory director, laboratory specialist, veterinarians and laboratory technical personnel based on the documents taken from the profession chambers they are attached to.
b) Operation document taken in accordance with work health and work security Regulation.
c) The technical specification and the capacities of the tools and the list of chemical and biological material to be used during diagnosis, analysis and production.
ç) Document showing the number and specializing fields of the laboratory specialists who shall work in the laboratory.
d) If the workplace to be opened is a company then the Commercial Registry Gazette indicating the establishment of the company.
e) Document taken from the fire department showing that the necessary precautions are taken for fire and explosions.
After the inspection of the documents by the Ministry, the laboratory is locally inspected and the opening report seen in Annex 2 of the Regulation is prepared by a commission formed including one authority from the Ministry, two specialists from the related institute and a veterinarian from the province directorate animal health department.
A work permit is given to the laboratories doing analysis and diagnosis, and an operation permit is given to the laboratories producing veterinary health products if they are found suitable from the technical and hygienic points. Work permits and operation permits are given to the resident address on behalf of real or legal persons, government institutions and organizations. These are announced to the Governorship’s Office in writing.
CHAPTER THREE
Sections of the Veterinary Diagnosis and Analysis Private Laboratories and Health Products Production Private Laboratories, Minimum Technical and Hygienic Conditions of the Sections
Cadastral extracts and sections of Veterinary Diagnostics and Analysis Private Laboratories
Article 7 - The following sections should be found in the private diagnosis and analysis laboratories:
a. Administrative section.
b. Autopsy rooms.
c. Laboratory units and nutrient medium preparation section.
ç. Guinea pigs section
d. An incinerator suitable to the valid norms
The diagnosis and analysis laboratories cannot be in the same location with the veterinary health product production laboratories.
Plied with GLP rules shall be com in the laboratories where the diagnosis and analysis services are realized.
Sections of Veterinary Health Products Private Production Laboratories
Article 8 - Laboratories producing products such as vaccines, sera, dilution liquids, biological materials, chemicals, immune modulators, probiotics, competitive exclusions, chemicals not to be used for treatment purposes and diagnostic agents should be in a detached building. If a laboratory is going to be opened in a separate building constructed for some other purpose, the establishment permit must be taken after making the necessary modifications according to the rules of this Regulation and approval of the Ministry on project and plan basis. Such a laboratory should include the following sections:
a. Administrative section
b. Laboratory sections (Viral, Bacterial, Parasitic etc.)
c. Units of laboratory sections (sub sections)
ç. Sterilization section
d. Quality control section (Control laboratory)
e. Preservation section, cold store, deep freeze rooms or deep freezers
f. Packing, packaging, store and transport sections
g. Incinerator in accordance with the valid norms
h. Test animals section
GMP and GLP rules shall be followed in the laboratories producing materials like vaccine, serum, dilution liquid, biological material, chemicals.
CHAPTER FOUR
Matters Related to Responsible Laboratory Director
Duties and Responsibilities of Responsible Laboratory Director
Article 9 - It is compulsory to have a responsible laboratory director working in these laboratories. The subjects related to the duties, responsibilities and assigning of responsible laboratory directors are indicated below:
a) The responsible laboratory director is responsible from the operation of the laboratory in compliance with the provisions of this Regulation, from doing healthful diagnosis and analysis or producing veterinary health products, health check ups and training of the working personnel, and from taking appropriate precautions to prevent the wastes and residues to harm the public and environmental health.
b) In the diagnosis and analysis laboratories, the responsible laboratory director is responsible from keeping records of the order no, sort and kind of material taken for examination, the diagnosis and analysis method applied, the name of the applicant and his address, the results of the diagnosis and analysis into a protocol and counter foiled report book or have them kept; and in a production laboratory, the responsible laboratory director is responsible from keeping the log of the name, series, harvest number, production date and amount, control date, place and results of the veterinary health products produced into a production control and protocol book, or have them kept.
c) The responsible laboratory director is responsible from complying with the provisions indicated in this Regulation, keeping the inspection books and to show the information and documents included in this Regulation to the authorities if required.
ç) The owner of the laboratory is obliged to provide all kinds of tools, material and facilities that the responsible laboratory director shall use while doing his duty.
d) The responsible laboratory directors cannot work in any other job during his work hours.
e) The responsible laboratory director is responsible from preparing the general cleaning and maintenance and work plans and programs.
CHAPTER FIVE
Laboratory Units and Its Responsibilities
Laboratory units
Article 10 - Laboratory units are organization units established in the laboratories to better perform the diagnosis and analysis works and production activities. Diagnosis and analysis laboratories covering a lot of units and veterinary health products production laboratories are obliged to hire veterinarians who are either specialized or made an academic carrier in their related field in each laboratory unit established according to the type and variety of the material produced.
Tools and Equipment
Article 11 - The diagnosis and analysis and production laboratories are obliged to keep sufficient amount and capacity of tools, equipment, biological material and chemicals in their laboratory units.
The list of tools and equipment existing in the laboratory is announced to the provincial directorate in order to be sent to the Ministry once in a year.
Protocol and report book, and production and control protocol book
Article 12 - A protocol and a counter foiled report book should be available in the diagnosis and analysis laboratories to record the order number, the sort and kind of material taken to examination, diagnosis and analysis method applied, the name and the address of applying person and the results of diagnosis and analysis.
A production and control protocol book should be available in the production laboratories to record the name, serial number, production date and amount, control date, place and result of the veterinary health product produced.
Inspection book
Article 13 - The laboratories are inspected by a specialist from the institute they are attached to concerning the veterinary services and a veterinarian from the animal health directorate of the provincial directorate they are attached to at least once a year and without considering the time if felt necessary. The facts determined during these inspections are recorded in the inspection book and this book is kept by the responsible laboratory director. The laboratory is warned by the provincial directorate on the violations determined during the inspection to get rid of them as soon as possible; and the laboratory is obliged to fulfil its duties within 15 days after the warning and inform the provincial directorate of the precautions they took, in a report.
These kinds of laboratories are inspected by a Ministerial authority assigned by the Ministry, if deemed necessary by the Ministry.
Informing of diagnosis, analysis and production
Article 14 - The examination results of the diagnosis and analysis laboratories are communicated to the provincial directorate in order to be sent to Ministry.
Every production of veterinary health products produced in the production laboratories are communicated to the provincial directorate to be sent to the Ministry.
The diagnosis and analysis laboratories are obliged to follow the diagnosis standards determined by the Ministry.
Notification of infectious diseases
Article 15 - If a disease which is obligatory to inform according to the Law on Animal Health Security dated 8.5.1986 no: 3285 and Regulation on Animal Health Security put into force by the Decree of Council of Ministers, dated 22.21989 no: 89/13838, is determined in the material brought to the laboratory for diagnosis and analysis the provincial directorate and institute directorate to which it is connected concerning the veterinary services are informed by the quickest means by the responsible laboratory director. The responsible laboratory director is responsible to the Ministry to perform this duty.
Personnel Notification
Article 16 - A list of the personnel working is prepared by the laboratory to inform the provincial directorate and to be sent to the Ministry. It is also obligatory for the laboratory to inform the personnel who left the job by his own wish or by the laboratory's disposal to the provincial directorate to be sent to the Ministry within one month. If the responsible laboratory director leaves the job then it is compulsory according to the provisions of this Regulation to start a new responsible laboratory director to work within one month. Otherwise work and operation permits are cancelled. In laboratories where more than one laboratory specialist exists for different subjects, if any one of these specialists leaves the job it is compulsory according the provisions of this Regulation to start a new specialist to work within one month. Otherwise, the products or the license of these products produced in that laboratory is cancelled.
Foreign persons being specialized or having done academic carrier cannot work by any means in the diagnosis and analysis laboratories and production laboratories without getting work permits in our country in the frame of related laws and Regulation, they cannot take place in any kind of operation. If such a work or operation occurs in the mentioned laboratories the work or operation permits of the laboratory is cancelled.
Training
Article 17 - Attending of the personnel working in the laboratory to the courses and in-service trainings arranged by official or professional organizations related to the subjects the laboratory is working on aiming to increase their technical and professional knowledge in parallel to the recent advancements is provided by the laboratory management paying all their expenses.
Diagnosis and analysis report and production control report
Article 18 - The diagnosis and analysis reports and production control reports prepared by veterinary diagnosis and analysis laboratories and veterinary health products production laboratories, the reports prepared by official and private laboratories about the diseases the notification of which are compulsory according to the Law on Animal Health and Security no:3825 and the provisions of the Regulation on Animal Health and Security no 3285, put in to force by the Council of Ministers and related to diseases foreseeing indemnities, becomes clear only after the control and approval of a reference laboratory authorized by the Ministry.
Records necessary to be kept
Article 19 - A recording and archive system answering the operation field, needs and specific functions of the laboratory shall be kept. Filing, comprehensibility, security and secrecy rules are complied with in the recording system. Protocol books and inspections books are used only after each and every page is numbered and stamped by the Animal Health Directorate of the provincial directorate to which laboratory is attached to. These books are kept for five years.
CHAPTER SIX
Production Permit of Veterinary Health Products and Production Control
Production permit
Article 20 - It is compulsory to take production permit from the government to produce veterinary health products. For getting the production permit the laboratories should apply to the Ministry with a petition including the following information and documents.
a) The photocopy of the operation permit of the laboratory given by the Ministry.
b) The opinion of the Ministry about whether the veterinary health products can be produced in this laboratory or not.
c) The trade name of the veterinary health products to be produced
ç) The using prospectus of the veterinary health product to be produced for the first time.
d) Production and protocol of the veterinary health products to be produced.
e) The commercial packaging and amount in the package of the veterinary health products to be produced.
f) The photocopy of the diploma of the specialist or the veterinarian showing that he/she is specialized or has an academic carrier on the related veterinary health products, according to the type and variety of the products and the contract signed having the approval of the notary.
g) List showing the technical specification of the tools and equipment to be used in the production of the product to be produced.
h) The label prepared for the product to be produced.
It is compulsory that the label necessary to be put on the product produced must have on it the name of the product, last day of usage and serial number. The labels having these information on it should be offset printed in order to prevent any erasure or scrape.
Production permit is given to the laboratories found suitable by the Ministry after the investigation of the information and documents sent and inspection done on-site by a commission formed by the Ministry. Production and control protocol is approved by the Ministry and sent to the institute directorate responsible from the control of veterinary health products assigned by the Ministry and from the applicant.
Production permit is given on product basis. The laboratory is obliged to apply to the Ministry once more for every product they want to produce. In such a case which of the information and documents shall be requested shall be determined by the Ministry.
Building and personnel conditions
Article 21 - Biological veterinary products are produced only in places to which production permit is given by the Ministry. The products which the producer wants to produce should be produced according to GMP, have the quality control done, produced in a production laboratory which owns enough sized buildings, equipment and personnel, the suitable technology and the laboratory facilities and determined and approved by the Ministry.
The following documents should be enclosed to license application for the products produced in other countries:
a) The document showing that the producing company is authorized to produce the subject veterinary health product in his country,
b) The document approved by the official authorities of the country where the product is produced, showing that the company does the production according to GMP rules and is inspected in this manner.
The Ministry may visit the units in which the production is done outside the country and examine the production and control operations if deems it necessary from product quality side. The producer and the related official authorities of the country where the producer is are informed beforehand that this examination shall be materialized.
Production on order and control
Article 22 - If the applicant is not a producer himself he is obliged to include the production contract he signed with a producer who has the conditions provided for on Article 21 of this Regulation.
If certain steps of production or a part of control operations are going to be done in different places this situation is to be mentioned in the application. It is obligatory that these places have the Ministry approval. The contract between the applicant and the production and/or control places that are going to run the operations, showing their responsibilities should also be submitted as an Annex of the application.
Responsibility of the Applicant
Article 23 - Information given in relation to a product should be correct, tested and true in a petition of license application for a biological veterinary product. The applicant is responsible from the correctness of the information and documents given, applicability of the methods and at necessary sensitivity.
Returning of Application
Article 24 - An application is rejected and returned to the applicant after the first examination of the Annexes of the application for a license to a biological veterinary product if the following are determined:
a) The applicant does not have the specifications foreseen in this Regulation.
b) Not suitably preparing and/or not submitting the Annexes requested in this Regulation during the application to be made to Ministry.
c) Information and documents submitted with the application are being incomplete or not related with the product.
ç) Finding that the production place is not suitable for producing the product.
Evaluation of the Applications
Article 25 - Production permit is given to the laboratories found suitable by the Ministry after the investigation of the information and documents sent and locally examining the laboratory by a commission formed by the Ministry. The production and control protocol is approved by the Ministry and then is sent to the institute directorate determined by the Ministry, responsible from the control of the product by way of applicant. Ministry considers the following facts while evaluating applications:
a) Ministry inspects on-site the storing areas, production areas, personnel, tools and material and distribution system of the applicant in relation with the product for which permit is requested. The authorities of the production laboratories, which are being inspected, are obliged to supply and show the necessary information and documents during the inspection.
b) The clinical pharmacological tests planned and done aiming to determine the effectiveness and safety of the product mentioned in the production and control protocol prepared for the product to be produced must prove the effectiveness and safety of the product usage for foreseen indication and under normal using conditions.
c) The announcements about the effectiveness and safety of the product under normal using conditions are not accepted as valid if they are not supported scientifically.
ç) The effectiveness and safety of the product to be produced should be supported and proved with the studies done and published by various specialized researchers.
d) Required laboratory analyses are done by the Ministry to determine, the applicability of the methods used in controlling the product by the producer, and correctness of the formula. The Ministry requires from the applicant to have the controls done at a suitable place if it is impossible to do it himself.
e) It is necessary to have the studies done on the subject that the product to be produced shall be matching the specifications all through its shelf life.
f) In case that the documents enclosed to the application does not include sufficient information about the product to be produced, further studies and recent information may be may be requested from the applicant. A verbal or written view may be requested from the applicant if it is necessary.
The refusal of the application to production permit
Article 26 - As a result of the evaluation of the application for having a license for a veterinary biological product, the application is refused if the followings are determined:
a) The product has harmful effects under normal usage conditions (the potential risk greater than curing effect).
b) The effect of the product is not sufficient or that this cannot be proved.
c) There is no benefit in offering the product to the market.
ç) The product does not suit to its specifications
d) Although the applicant is warned that no result can be reached although the informed control methods are applied or the specifications are beyond the acceptable limits and the applicant cannot correct this and it is found out in the second inspection that unsuitability continues.
Notification and objection
Article 27 - If a license application is refused then the applicant is informed with reasons. The applicant has the right to object to the decision. While the objection is being discussed the applicant may be given the written and/or verbal explanation and defence right.
Production control
Article 28 - The first control of the veterinary health products found suitable and permit given by the Ministry is done in the control laboratory existing in the production laboratory where the product is produced, and the name, serial number, production date, amount, date and place of control and date of expire and control results are recorded into production and control protocol book. Later on, samples taken according to the rules and in sufficient amounts by a commission formed by the institute and province directorate assigned by the Ministry are marked with a label filled by the commission and is stamped together with the sample records and is taken under signature. The mentioned samples taken by the commission are sent to the institute assigned by the Ministry, for quality control. Laboratory is obliged to arrange the form showing the qualitative and quantitative specifications of the sample taken by the commission and send it to the institute directorate.
If in case of an objection to the control results the test is repeated a second time in an institute found suitable by the Ministry. The result obtained is decisive.
Sale permit
Article 29 - The samples found suitable after determination of the trade name, serial and harvest no, production date, amount and date of expire, selling is permitted by the Ministry. Sale of the products without control and label is forbidden.
The products, which get the sale permit, are announced to the provincial directorate by the Ministry. Products found unsuitable are fixed in a record by a commission determined by the Ministry. These products are annihilated according to the instructions to be prepared by the Ministry.
CHAPTER SEVEN
Penalty Provisions, Closing and Changes
Penalty Provisions
Article 30 – In cases that the laboratories do not fulfil the obligations and responsibilities written in this Regulation or lost the capacity, not correcting the violations found during inspections in spite of warnings, not assigning a new responsible laboratory director within one month when a responsible laboratory director leaves the job, doing the diagnosis and analysis and producing veterinary health products not found suitable by the Ministry, supplying markets with products even though no sales permit is given by the Ministry and selling the product without label and control, the work and production permits of such laboratories are cancelled in compliance with the provisions of Law on Animal Health and Security no:3285 and provisions of Regulation on Animal Health and Security. If a responsible laboratory director resigns and no new responsible general director is assigned within one month then the produced products and product licenses are cancelled.
Closing, changes and additions
Article 31 – In the laboratories who have taken work permits or operation permits, no changes or additions like renewal of the laboratory partially or wholly, increasing or decreasing the production capacities of the laboratories, adding new laboratory units in order to produce new veterinary health products, can be done without the permission of the Ministry. In cases when Ministry permits such changes the information and document mentioned in the Regulation may be requested once more. The work or operation permit given is valid only for the real or legal persons, address and operation field written on it. If any one of them changes than the production permit or operation permit looses its validity. If the laboratory is going to be closed by the owner, or changes owner or name, a petition informing the situation is given to the governorship to be sent to the Ministry one month in advance. Related information and documentation about the changes and original copy of the work permit or operation permit is enclosed to the petition to be sent to the Ministry. Work permit for veterinary diagnosis and analysis laboratories and operation permit for veterinary health products production laboratories is given to the new owner or name if it is found suitable by the Ministry.
In cases when the work or operation permit is lost or damaged such that it is no more legible, governorship is applied with a petition including the newspaper showing the loss announcement or the original copy of the damaged work or operation permit. A new work or operation permit is prepared with the old date and number giving necessary explanations if it is found suitable by the Ministry. In cases when the operation of the laboratory is stopped or the laboratory is closed the situation is announced to the governorship in writing.
CHAPTER EIGHT
Preparation of Instructions, Work Permits or Operation Permits
Preparation of Instructions
Article 32 – The instructions related to the application of this Regulation are prepared by the Ministry.
Preparing work permits or operation permits
Article 33 – Work permit to the laboratories doing animal diseases diagnosis and analysis and operation permits to the laboratories producing veterinary health products to be used against animal diseases, who had already fulfilled the rules of this Regulation and been found suitable by the Ministry, are prepared and given by the Ministry.
CHAPTER NINE
Miscellaneous and Final Provisions
Legislation that are no more valid
Article 34 – The Regulation on Veterinary Diagnosis Private Laboratories and Veterinary Biological Material Production Private laboratories published in the Official Gazette dated 7.11.1995 no: 22456 looses its validity together with its additions and amendments after the publishing of this Regulation.
Temporary Article 1 – The following is applied to the already operating laboratories:
a) The laboratories who had been established before the publishing of this Regulation and were given work or operation permits in accordance with the Regulation of Veterinary Diagnosis Private Laboratories and Veterinary Biological Material Production Laboratories published in Official Gazette dated 7.1.1995, no: 22456, are obliged to apply to the Ministry within at most six months to arrange their laboratories in accordance to the rules of this Regulation and get new work or operation permits. The old information and documents shall be considered by the Ministry and additional information and documents may be requested if necessary and new work or operation permits shall be given after local investigation if felt necessary.
b) The laboratories that had been established before the publishing of this Regulation but did not get their work or operation permits are obliged to apply to the Ministry, arrange their laboratories according to the rules of this Regulation and get new work or operation permits within six months from the day of publishing.
c) Operations shall be performed to the ones who did not apply in the given period according to the Animal Health and Security Law no:3285 the rules of the Regulation on Animal Health and Security Published by the decision of the Council of Ministers in Official Gazette dated 22.2.1989 no:3285. The laboratory shall be closed until it fulfils its obligations.
Enforcement
Article 35 – This Regulation enters into force on the date of its publishing.
Execution
Article 36 – The provisions of this Regulation are executed by the Ministry of Agriculture and Rural Affairs.
ANNEX 1
STATEMENT
| 1- | a) Name and Surname of owner | : |
| b) Trade name | : | |
| c) Open Address | : | |
| d) Telephone No | : | |
| e) Fax No | : | |
| f) No of block, sectional map and plot | : | |
| of the laboratory to be established. | ||
| 2- | Operation field | |
| a) Diagnosis and Analysis | : | |
| (Which diagnosis and analysis shall be done) | ||
| b) Production | : | |
| (Which production or productions shall be done) | ||
| 3- | Explanation report related to operation field of the Laboratory | : |
| 4- | Expected starting date for the investment of laboratory | : |
| Owner of Laboratory Name and Surname Date and Signature |
||
ANNEX - 2
OPENING REPORT
| 1- | a) Name and Surname of owner | : |
| b) Trade name | : | |
| c) Open Address | : | |
| d) Telephone No | : | |
| e) Fax No | : | |
| f) No of block, sectional map and plot | : | |
| of the laboratory to be established. | : | |
| g) Activity field | : | |
| 2- | Whether the laboratory is built in accordance with the projects existing during taking establishment permit or not | |
| a) Built in accordance b) Not built in accordance | ||
| 3- | Whether the works have operation certificate in accordance with the By-Law on Worker Health and Vocational Safety or not | |
| a) Yes, it has b) No, it has not | ||
| 4- | Whether there is a document taken or not from fire department showing if the necessary precautions are taken or not regarding fires or explosions | |
| a) Yes there is b) No there is not | ||
| 5- | Whether there are contacts signed by the technical director and responsible veterinarian approved by notary or not | |
| a) Yes there are b) No there are not | ||
| 6- | Are the technical specifications and capacities of the tool and equipment to be used in the laboratory units of the diagnosis and analysis / production laboratories are sufficient? | |
| a) Yes they are b) No they are not | ||
| 7- | Is the number of laboratory specialists, veterinarians, laboratory technical personnel and laboratory technicians to work in the laboratory units are sufficient? | |
| a) Yes it is b) No it is not | ||
| 8- | The findings and observations as a result of on-site inspection: | |
| It is suitable/ not suitable to give opening report for the diagnosis and analysis / production laboratory. (Reasons) | ||
| Ministerial authority | Institute Dir. Authority | Institute Dir. Authority | Prov. Dir. Authority |
| Veterinarian | Exp. Veterinarian | Exp. Veterinarian | Veterinarian |