Home | Registration of feed additives and veterinary drugs in Kazakhstan
Registration of feed additives and veterinary drugs in Kazakhstan
According to the laws of the Customs Union, feed additives and veterinary drugs must be registered with the Ministry of Agriculture and registration tests must be carried out. Our specialists with many years of experience compile technical dossiers in accordance with the rules of the Ministry of Agriculture of the Republic of Kazakhstan. To compile a technical dossier, the following documentation is required:
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SUMMARY OF PRODUCT CHARACTERISTICS:
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Manufacturer's details: name, address, phone/fax number, e-mail (The same information for the Applicant)
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Trade name of the product
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Packing
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Detailed composition
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Store conditions and shelf life with indication of temperature range for storage (from… to..)
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Pharmacological/biological properties
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Animal species
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Indications for use
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Contraindications
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Special precautions
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Special precautions for persons administrating drug to animals
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Adverse reactions (frequency and seriousness)
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Use during pregnancy, lactation or lay
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Interactions with other medicinal products and other forms of interactions
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Amount(s) to be administered and administration route
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Overdose (symptoms, emergency procedures, antidotes), if necessary
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Withdrawal period(s)
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Clinical, preclinial or bioequivalence study
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Any other information you consider appropriate to specify.
TECHNICAL INFORMATION:
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Packaging specifications
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Raw materials specifications
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Product information: name, appearance, color, odor , etc.
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Determination Methods of the active substances
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Certificate of Analysis
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Production process: description and scheme
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Specification of manufacturing equipment
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The Power of Attorney sealed and signed
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GMP Certificate (if any)
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Trial reports, safety, tolerance, effectiveness
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Free sales certificate or marketing authorization
The first time issued registration certificate of feed additives is valid for 5 years, after it should be renewed. Once it is renewed the new certificate will be termless.
If you have any questions or need assistance, please do not hesitate to contact us. Our specialists will provide quick and efficient solutions. We also offer competitive pricing for our services, so you can be confident that you are receiving quality assistance at a reasonable cost. Contact us today to learn more!