Classification Of Medicinal Products Order

Original Language Title: Zāļu klasifikācijas kārtība

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: https://www.vestnesis.lv/ta/id/122149

Cabinet of Ministers Regulations No. 885 in Riga 2005 22 November (pr. No 68 26) classification of medicinal products order Issued in accordance with article 5 of the pharmaceutical law paragraph 10 of article 10 and paragraph 13 1. determine drug (excluding veterinary medicine) classification. 2. the National Agency for medicines, deciding on registration (Reregistration), simultaneously also provides the medicine belonging to one of the following classifications: 2.1. drugs, which requires medical treatment person writing instruction: 2.1.1 designed recipe primary or secondary outpatient treatment (prescription drugs);
2.1.2. the record of hospital hospital's medical documentation;
2.2. the drugs which can be used without medical treatment person's written instructions issued (hereinafter referred to as non-prescription drugs). 3. the prescription drug groups down the halls, which meet at least one of the following criteria: 3.1, even using medications properly, without the supervision of a person's treatment could cause direct or indirect risk to human health;
3.2. the grass is often used too large quantities and wrong, thus creating a direct or indirect risk to human health;
2.1. drugs contain substances or mixtures of substances of which the activity or side effects is required in addition to study;
3.4. the medicinal product is normally intended for parenteral use (medicines, without affecting the digestive tract);
3.5. medicinal products containing substances in significant amounts in included in Latvia controlled narcotic substances, psychotropic substances and precursors in list II or III;
3.6. use wrong, they pose a risk of medical use, abuse, dependence or can be used for illicit purposes;
3.7. the medicinal product contains substances which did not use sufficient experience (novelty) or properties as a precaution, these provisions constitute 3.6. medicinal products mentioned in points;
3.8. the medicinal product is intended for the treatment of the disease, which is diagnosed in hospital medical institutions or other specialized treatment in institutions, have appropriate diagnostic capabilities. Further use of the product and the additional activities may take place outside these medical institutions;
3.9. the medicinal product is intended for outpatient treatment, but may cause greatly from the present side effects which require the use of industry guidance and supervision throughout the treatment period. 4. The rules referred to in point 2.1.2 class down the Hall, the use of which the pharmaceutical characteristics or lack of experience of the use of, or the (novelty) in the interests of public health, only for treatment in hospital. 5. the State Agency of medicines has the right not to apply this provision to medicinal products 3 and 4 the criteria referred to in paragraph 1, if the maximum single dose of the medicinal product, the maximum daily dose, the strength, the pharmaceutical form, the type of packaging or other usage conditions are those which do not pose a risk to the safety of the use of the product. 6. Medicinal products which do not comply with these rules 3 and 4 the criteria referred to in paragraph or in accordance with the provisions of paragraph 5 of the State Agency of medicines shall not apply in paragraph 3 and 4 above criteria, belong to the non-prescription medicines. 7. the State Agency of medicines and regularly (at least once a year) articulates in Latvia registered medicinal products of the European Medicines Agency and the centralised registration procedure established in the territory of Latvia distributed a list of medicinal products (hereinafter list). Medicinal products belonging to this provision in point 2.1.1 and 2.1.2. mi tax group list specifies the designation "Pr". Non-prescription medicinal products, the designation does not specify. Medicines in the list indicates also the anatomic therapeutic chemical classification code. 8. in addition to the provisions referred to in paragraph 7 of the State Agency of medicines shall use the following notation: 8.1. Pr. I-narcotic and psychotropic drugs pielīdzinātaj them;
8.2. Pr-this provision II 3.8, 3.9 points and bottom 4. medicinal products referred to in paragraph 1. 4. These provisions on medicinal products referred to in additional notes the designation "stac.". 3.9. Those provisions in such products in addition to provide medical specialty;
8.3. Pr. III – prescription medicine government agency recognized as Narcotic analgesics for means or psychotropic drugs, which do not belong to these rules referred to in point 8.1. 9. If a State Agency of medicines of the medicines become aware of new information, the Agency will assess the information and, if necessary, shall take a decision on the amendment of the list in respect of the classification of medicinal products, taking into account this provision 3, 4, 5, and 6. the criteria referred to in paragraph 1. 10. If the decision on the amendment of the list in respect of the classification of medicinal products is based on significant pre-clinical tests or clinical trials, the drug, a government agency, when considering submissions, a year after the amendment did not apply this test or survey results to the classification of the same substance, the changes made by another applicant for or holder of the registration certificate. 11. the State Agency of medicines shall annually inform the other Member States of the European Union and the European Commission of amendments made to the list as regards the classification of the medicinal product. 12. a national medicines agency maintains the database, which contains the list of medicinal products with the anatomical therapeutic chemical classification and defined daily dose (ATC/DDD). 13. Be declared unenforceable in the Cabinet of Ministers of 20 March 2001 No. 138 of the rules "rules for the classification of medicinal products prescription and non-prescription medicinal products" (Latvian journal, 2001, no. 52, 111 no; 2003). Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 6 November 2001, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
2) of the European Parliament and of the Council of 31 March 2004, Directive 2004/27/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Prime Minister a. Halloween Health Minister g. Smith