The answers to the questions
1. What is the difference between food and dietary supplements?
Food additives are natural or artificially synthesized compounds which are used in cooking to give her certain flavor characteristics or preserve the quality of food. To food additives are colorants, stabilizers, emulsifiers, preservatives.
Nutritional supplements are called natural or identical biologically active substances, which serve as an additional source of essential nutrients and optimize protein, carbohydrate, fat, vitamin and other types of exchange. BAD be added to foods or taken with her, he is a Wellness component, normalizing the functional state of organs and systems. Biologically active additives have a restorative, sedative, tonic, mild diuretic action, reduce the risk of diseases, normalize the intestinal microflora.
2. What is the difference between the study of bioequivalence and therapeutic equivalence study?
Bioequivalence study of a medicinal product is its clinical study to determine the rate of absorption of pharmacological agents from the intestine and its excretion from the body, as well as the amount of drug reaching the systemic blood flow. The results of this study to draw conclusions about bioequivalence of medicines in the proper dosage and the form of the corresponding original drug.
The therapeutic equivalence study is a clinical study that can identify homogeneous properties of pharmacological drugs of specific dosage forms and the same indicators of their safety, efficacy and clinical effects.
3. Is there a difference between the labelling of drugs for veterinary use?
Legislated labeling of drugs for veterinary use are subject to strict conditions, which the manufacturer has no right to retreat. On their primary and secondary packaging, in addition to readable name of drug (INN and trade name), batch number, date of issue, expiry date, dose, concentration and volume, there should be a warning inscription "for veterinary use".
4. What information should be marked on the package of the medicine?
If the drug is manufactured, not the pharmacy organization special veterinary pharmacy or the individual entrepreneur having a license for this activity, it may come into circulation only if the rules for labelling specified in the Federal law dated 11.10.2010 No. 271-FZ.
The primary packaging is clear and understandable should be written in the Russian name of the medicinal product (chemical and trade), batch number, expiry date (for immunobiological advanced â€” release date), dosage, amount in packaging, the number of doses or activity in units of action. Exception â€” the primary packaging of herbal medicines.
Secondary (so called consumer) packaging must contain the following information: name (trade and chemical) drug, information about the manufacturer, dosage form, batch number and the registration certificate, shelf life for immunobiological preparations optionally, the date of issue, method of application, the volume in the package, dosage or concentration, number of doses or activity in units of action, conditions of supply and storage, and warning labels. So, in preparations of blood and plasma is applied to the inscription on the absence of antibodies to the viruses HIV, hepatitis b and C, plant â€” that they passed radiation monitoring. The secondary packaging also applied the barcode (46 h of the Law "On circulation of medicines").
5. Prompt, please, can you supply substance lidocaine hydrochloride for the manufacture of sterile dosage forms?
Hello! In the registration information, the substance for pharmaceutical and veterinary medicine lidocaine hydrochloride "GOROS21.RU" it is specified that it can be used for the manufacture of sterile dosage forms.
6. Can you help in obtaining GMP certificates and techniques of analysis from manufacturers of pharmaceutical and veterinary substances?
Of course, we have constantly practiced this type of service. Company GOROS21.RU officially imports the products from trusted suppliers and manufacturers, therefore, provides a complete set of documents for the products. We also render free advice to clients on the application of the substances.
7. Hello, can you assist to register our products in Russia, in Ministry of Health and Ministry of Agriculture?
Yes, we can help you to prepare your documents and consult about the registration process. "GOROS21.RU" Co. Ltd. offers for all world traders and factories to register their products at RF. Please, if you have any question, contact us.