The Provisions On The Labelling Of Medicinal Products And Pharmacovigilance Requirements For Izvirzāmaj Instructions

Original Language Title: Noteikumi par zāļu marķēšanas kārtību un zāļu lietošanas instrukcijai izvirzāmajām prasībām

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/126348

Cabinet of Ministers Regulations No. 57 in Riga in 2006 (17 January. Nr. 3 21. §) rules on the labelling of medicinal products and pharmacovigilance requirements izvirzāmaj the instruction Issued in accordance with article 5 of the law on Pharmacy 3 and 12 point i. General questions 1. determines the procedure for labelling of medicinal products and pharmacovigilance instruction (hereinafter referred to as the manual) sliding.
2. the rules shall not apply to: 2.1 veterinary medicinal products;
2.2. intermediate products intended for further processing by the licensed manufacturer of the medicinal product;
2.3. medicinal products intended for research and development trials, except for the requirements arising from legislation on drug clinical trials and observational procedure of use;
2.4. for radionuclides (radioactive isotopes) in the form of sealed sources.
2.5. the whole human blood, plasma or blood cells, except for plasma which is prepared industrially.
3. the information on the labelling of pharmaceutical primary packaging (which is in direct contact with the medicinal product) and the secondary packaging (which contains the primary package), as well as the information in the operating instructions stated in accordance with the State language requirements set out in law.
4. If a medicinal product imported in Latvia (except drugs imported and stored, to the other Member States of the European Union or third countries), the information on the label is not specified, the language of the country of Latvia prior to their distribution to be affixed to the packaging of the product label with the label in a translation of the information provided in the national language.
5. Operating instructions include the secondary packaging of medicinal products, except where the rules in paragraph 7.3 and paragraphs 14 and 15 above information is indicated on the secondary or primary packaging, as well as these regulations 7.6. in the case referred to in subparagraph. If the secondary package is concluded in the State (for example, sealed) that cannot be opened without damaging the packaging, instructions for use of the national language may be attached to the secondary packaging.
6. Label with the label in a translation of the information provided in the national language to be affixed to the packaging of the medicinal product and the operating instructions included in the secondary packaging or attached to the packaging of medicinal products in the primary before distribution (does not apply to products imported and stored, to) launch in Latvia. These requirements provide the registration certificate holder (owner) or special permission (license) for the manufacture of medicinal products or/and the import from third countries of the holder (owner), or parallel imported medicinal product authorisation for distribution to the holder (owner).
7. the labelling and package leaflet shall meet the following requirements: 7.1 the registration of medicinal products subject to labelling and instructions for use, information is provided in accordance with the documentation submitted for registration and the requirements set out in these provisions. Permissible differences between the parallel import of medicinal products, labelling and the package leaflet pursuant to paragraph 7.11. these provisions;
7.2. the provisions of paragraphs 10 and 11 and the marking referred to in point 7.3 data is easily legible, clearly comprehensible and indelible;
7.3. the secondary packaging and instructions for use symbols (labels) or pictogram (stylized images of information signs), in order to clarify this provision in paragraph 10 or 14 and 15 the information referred to in paragraph 1 and the other with the summary of the relevant information that is appropriate to the patient, but no advertising elements;
7.4. This provision 10, 14 and 15 and paragraph 7.3. labelling referred to in point data can be in several languages, provided that the data provided in all languages are the same. Particular on orphan medicinal products (medicinal products which have been granted such status in accordance with the European Parliament and of the Council of 16 December 1999, Regulation (EC) No 141/2000 on orphan medicinal products terms and conditions) of these rules on labelling referred to in paragraph 10, upon reasoned request, the data may be provided only in one of the official languages of the European Community;
7.5. the manual is written and presented in a clear and understandable. If necessary, the user may refer to the following help health care professionals. Instructions for use are clearly legible. It can be printed in several languages, provided that the information provided in all languages have the same;
7.6. If the product is not intended for delivery directly to the patient (for example, for medical institution of treatment person's direct presence or supervision), the State Agency of medicines has the right to be exempted from the provision of individual data label and instructions for use in accordance with these rules. Delivering medication treatment authority, the consignment must be at least one labelling of the medicinal product concerned and a translation of the instructions for use of the national language. The supplier of the medicinal product provides the necessary number of translations of the marking and instructions for use in the national language according to the hospital's demand;
7.7. the rules referred to in paragraph 15.1. special conditions for certain categories of users (patients with specific pathological conditions) can be specified in the instructions at the bottom of the intended only for treatment. Before the issuance of the instruction to the patient, the medical person or pharmacist the instructions part of the tearing off of the end;
7.8. the package leaflet shall reflect the results of consultations with target patient groups (drug users) to ensure that instructions are clearly legible, accurate and easy to use;
7.9. the attached information (such as a label, primary packaging of medicinal products in the attached leaflet) must not conceal the package specified the name of the medicinal product, the expiration date and serial number of the manufacture of medicinal products. Adding information (including instructions for use into a secondary packaging of medicinal products or affixing the primary packaging) must not affect the quality of the medicinal product;
7.10. the package leaflet of the medicinal product is prohibited to print the secondary inside the package;
7.11. the parallel imported medicinal products, labelling and instructions for use by content corresponds to the Republic of Latvia register of medicinal products medicinal products included in the marking and instructions for use, in relation to which the parallel imports carried out (hereinafter referred to as the reference medicinal product). The differences are clearly indicated in the instructions for use. In addition to indicate parallel imported medicinal product distribution the holder (owner's) name and address, and the State Agency of medicines of the parallel imported medicinal product granted a distribution permit number, and the date when a parallel imported medicinal product distribution the holder (owner) last reviewed the the leaflet. If the parallel imported medicinal product labelling on the packaging is the therapeutic indications approved by the other Member States, but which are not approved by the Republic of Latvia register of medicinal products, in the cover with a sticker. Such differences are allowed on the label and in the instructions for use: 7.11.1. This provision 10.1 and 14.1.1. bottom of the medicinal products referred to in paragraph name, if the name of the medicinal product of reference differs from the parallel imported medicinal product name the country from which the importation of medicinal products;
7.11.2.10.4. these provisions and 14.6.4. the bottom point of the information set out in point – if the parallel imported medicinal product contains different excipients or dyes with different colour code than the reference medicinal product, and if it affects decomposition period;
7.11.3.14.6.7. This provision of the information specified in point – if the parallel imported medicinal product manufacturer name and address different from the reference product is specified in the instructions for use.
8. Free samples shall be in addition to the requirements laid down in these provisions be marked in the national language "free medical sample-not for sale" or other words with the same meaning. The label provides the registration certificate holder (owner) or his authorised person.
9. the requirements laid down in these provisions shall also apply to medicinal products, under Council of 28 March 1983, Regulation (EEC) No 918/83 establishing a Community system of reliefs from customs duties, imported by public authorities or public good organisations from third countries, as well as drugs that law acquired in accordance with the procedure laid down in the Member States of the European Union or imported from third countries on foreign financial assistance in accordance with the Government of the Republic of Latvia concluded contract , an international agreement or an international project that is registered in the Ministry of finance, and delivered to the recipient in Latvia. The recipient of such medicinal products provides additional labelling of "free". The following inscription indicates that the product must not be distributed for a fee.
II. Information on the label to Label 10. secondary packaging or, if not, to indicate the primary packaging:

10.1. the name of the medicinal product followed by the strength (depending on the pharmaceutical form of quantified the content of the active substance in the dosage, one volume or per unit mass) and the pharmaceutical form and, if necessary, provide an indication of whether it is intended for babies, children or adults. If the product contains up to three active substances, also indicate the international non-proprietary name (INN) or, failing that, a general name. Medicine may refer to: 10.1.1. name, which should not be confused with the generic name (the World Health Organization recommended international non-proprietary name (INN) or, if such is not recommended, the commonly used name);
10.1.2. General or scientific name accompanied by a trade mark or holder of the registration certificate (owner) name;
10.2. quality and quantified for each active substance (use a general name) contains a single dosage unit or according to the form of Administration for a given volume or weight;
10.3. pharmaceutical form and quantity of mass, volume or units of dosage;
10.4. the list of excipients which recognised effects are known and listed in the annex to these provisions. All excipients indicates, injectable for topical use (e.g. skin, mucous) and ophthalmological use adopt Thai medicinal products;
10.5. the route of administration and, if necessary, the route of administration of the medicinal product. Provides place to specify the intended dose, or a pharmacy label;
10.6. the special warning that the medicinal product must be stored out of the reach and sight of children;
10.7. other special alerts (if necessary);
10.8. the term of validity, indicating the month and year;
10.9. special storage conditions (if necessary);
10.10. specific precautions that must be followed, destroying unused medicinal products or waste materials from medicinal products (if necessary), as well as an indication that the unused product must be handed over to the pharmacy (where drugs need special disposal conditions);
10.11. the registration certificate holder (owner's) name and address and the registration certificate holder (owner) name of the representative, if one has been assigned;
10.12. the registration number of the Republic of Latvia or in the appropriate register of medicinal products of the European Medicines Agency registration number, if the product is registered in a centralized registration procedure in accordance with the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency;
10.13. the serial number of the manufacture of medicinal products. If drugs are repacked or pārfasēt, repacking or packaging, the serial number;
10.14. non-prescription medicinal products, instructions on the use of the product;
10.15. the manufacturer of the medicinal product (pārpakotāj or pārfasētāj) name and address, if the drugs are repacked or pārfasēt. A parallel imported medicinal product shall also in parallel imported medicinal product distribution the holder (owner's) name and address.
11. This provision of the information referred to in paragraph 10 on the primary packaging may not be specified in the following circumstances: 11.1. primary packaging, such as the Tablet plate is inserted into the secondary container to which this provision is specified in paragraph 7.3 and paragraph 10 of that information, but the primary packaging shall contain at least the following information: 11.1.1. name of the medicinal product in accordance with this rule 10.1.;
11.1.2. the registration certificate holder (owner) name;
11.1.3. period of validity;
11.1.4. the serial number of the manufacture of medicinal products;
11.2. the small size of the primary packaging units, which it is not possible to specify this rule 7.3. point and the information referred to in paragraph 10, except the following: 11.2.1. name of the medicinal product according to point 10.1. these provisions and, if necessary, the route of administration of the medicinal product;
11.2.2. the route of administration;
11.2.3. the period of validity;
11.2.4. serial number of the manufacture of medicinal products;
11.2.5. the quantity mass, volume or units of dosage.
12. This provision 10.1 referred to the name of the medicinal product and the strength of the secondary packaging or, if not, to indicate the primary packaging also Braille. If a registration certificate has been issued for only one strength, Braille only assigned names. This provision shall not apply to medicinal products the administering of which provides medical treatment person medical institution, for example, to vaccines.
III. the information in the instructions for use instructions for use 13. information in accordance with the summary of product characteristics. Parallel imported medicine instructions allowed this provision in paragraph 7.11. these differences.
14. Instructions for use in the following order: 14.1. information identification of the medicinal product: 14.1.1. name of the medicinal product followed by the strength and pharmaceutical form (if required), indicating whether it is intended for babies, children or adults. General name indicate if the product contains only one active substance and if its name is an invented name;
14.1.2. farmakoterapeitisk group or action (a patient to understand);
14.2. the therapeutic indications;
14.3. the information which is necessary before the medicinal product is taken: 14.3.1. contraindications;
14.3.2. precautions to be observed in use;
14.3.3. interactions with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product;
14.3.4. Special warnings;
14.4. the necessary and appropriate instructions for proper use of medicinal products, in particular: 14.4.1. dose;
14.4.2. the route of administration and, if necessary, the route of administration;
14.4.3. the frequency of administration, specifying if necessary, the time at which the medicinal product may or must be administered;
14.4.4. If necessary, depending on the nature of the product: duration, 14.4.4.1. If there are certain limitations;
14.4.4.2. action in case of an overdose of medicines (such as symptoms, emergency measures);
14.4.4.3. what to do when one or more doses have not been taken;
14.4.4.4. guidance on the consequences of the use of the medicinal product (if necessary);
14.4.4.5. specific recommendations to consult the doctor or the pharmacist, for any clarification on the use of the product;
14.5. the side effects that can occur when you use according to the instructions, and the appropriate action in this case, as well as request the patient to report the doctor or pharmacist about any operating instructions do not specify drug-induced side effects;
14.6. a reference to the expiry date indicated on the label, specify the following information: 14.6.1. a warning against using the product after the expiry date;
14.6.2. specific precautionary measures during storage of the medicinal product (if necessary);
14.6.3. for certain visible signs of deterioration of the medicinal product (if necessary);
14.6.4. the full qualitative composition (in active substances and excipients) and the quantitative composition of the active substance using General names, each drug design;
14.6.5. pharmaceutical form and amount of weight, volume or units of dosage, each drug design;
14.6.6. the holder of the registration certificate (the owner's) name and address and the registration certificate holder (owner) of the names of the representatives in the Member States (where such representatives);
14.6.7. drug manufacturer's name and address;
14.7. in each Member State, the registered name of the medicinal product, if the product in accordance with the provisions of the registration of the medicinal product are established in the mutual recognition procedure of registration and allowed the Member States concerned with different names;
9.2. date last revised instructions for the use of the medicinal product, as well as the identification number of the instruction of the State Agency of medicines.
15. providing that rule 14.3. of the information referred to in paragraph 1 below: 15.1. specific conditions for certain categories of users (children, pregnant women, breastfeeding women, the elderly, persons with specific pathological conditions);
15.2. possible effects of medicines on the ability to drive vehicles or to operate machinery (if necessary);
15.3. the adjuvants, which are important to know for safe and effective use of the medicinal product and which are included in the annex to these provisions.
16. the holder of the registration certificate (the owner) shall ensure that after the request of the organizations representing blind and low-vision patients, the information given in the instructions for use is available for blind and visually impaired in the appropriate way.
IV. A simplified registration procedure for homeopathic medicinal products registered, traditional herbal medicine and radiopharmaceutical and their raw material marking and instructions for use 17. If homeopathic medicinal products registered a simplified registration procedure, the labelling and, where appropriate, instructions for use, in addition to the clearly visible, the words "homeopathic medicinal product" indicates the following: 17.1. homeopathic stock or scientific name by using the European Pharmacopoeia or, failing this, of the Member States currently used symbols of the Pharmacopoeia (labels), followed by the degree of dilution. If the homeopathic medicinal product composed of two or more materials, homeopathic homeopathic scientific names of raw materials in the labelling may be supplemented by assigned names;

17.2. the holder of the registration certificate (the owner) and, if necessary, the name and address of the manufacturer;
17.3. types of use and, if necessary, the route of administration of the medicinal product;
17.4. the term of validity, indicating the month and year;
17.5. pharmaceutical form;
10.9. the trade package size;
17.7. special storage conditions (if necessary);
11.1. specific warnings (if necessary);
11.1. the serial number of the manufacture of medicinal products;
17.10. registration number in the Republic of Latvia register of medicinal products;
17.11. indication-"homeopathic medicinal product without approved therapeutic indications";
17.12. recommendations for the user to consult a doctor, if during the use of the medicinal product, the symptoms do not disappear.
18. the radiopharmaceutical (drugs that use the prepared form contains one or more radionuclides (radioactive isotopes) for medical purposes) transport packaging and containers shall be marked in accordance with the laws and requirements concerning protection against ionizing radiation, transport of radioactive materials. In addition to the labelling of such preparations comply with the rules in paragraph 10 and 19.
19. Highlighting the radiopharmaceutical preparations, the following additional conditions: 19.1. primary packaging (bottles) label: 19.1.1. name of the medicinal product or code, including the name of the radionuclide and chemical symbol;
19.1.2. serial identification data and expiry date;
19.1.3. radiation symbol;
19.1.4. manufacturer's name and address;
19.1.5. this rule 19.2. radioactivity dose referred or vial;
19.2. the secondary packaging labelling provides an explanation of the meaning of the code indicated on the primary packaging (bottles), and, if necessary, indicate the radioactivity dose vial or a specific time and date, as well as the number of capsules or solutions – millilitres.
20. the pharmaceutical preparations, radionuclide generator (any system used in a radiopharmaceutical, incorporating a fixed parent radionuclide from which is the leaching or another method produced a daughter radionuclide), Suite (any preparation to be transformable or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration) or any other radionuclide produced some other substances before they use the markup for radiological, package insert instructions , which contains information in accordance with the provisions of paragraphs 14 and 15, and in addition to any precautions which must be observed by the user and the patient during the use of preparations and relevant, as well as special precautions that must be followed, destroying the packaging and its unused contents.
21. Traditional herbal medicinal products (herbal medicines that meet the regulations for the registration of medicinal products laid down by the rules of traditional herbal medicine and established the criteria for a simplified registration procedure) on the label and in the instructions for use in addition to these regulations, paragraphs 14 and 15 in includes the following information: 21.1. indication that the product is a traditional herbal medicinal product with specific indications based solely on the basis of long-standing use;
21.2. indication that the user should consult a doctor or a qualified health care provider if the symptoms persist during the use of the medicinal product or resulting from side effects that are not mentioned in the instructions for use;
21.3. the indication of the traditional herbal medicinal uses.
V. the pharmacy medicinal product labelling made 22. If the medicinal product is made in the pharmacy in person the treatment prescription for an individual patient or after the hospital's request (the magistral formula) or they are manufactured according to the pharmacopoeia monograph and distributed to patients served by the pharmacy in question (the officinal formula), the labelling shall bear the following information: 22.1. pharmacy name, address and telephone number;
22.2. the patient's first and last names (children up to the age of 14gad points also) or treatment services and Department name;
22.3. the composition of the medicinal product;
22.4. the recipe specified the conditions for the use of the medicinal product (dose, route, route of administration, frequency of use);
22.5. drug production and date of issue;
22.6. the period of validity of the medicinal product (date, month, year);
14.1. issuing of the medicinal product name and signature;
22.8. This provision referred to in paragraph 23 the specific warnings (if not difficult);
14.2. instructions: "keep out of the reach and sight of children";
22.10. special storage conditions;
22.11. prescription number or medical authority number;
12/22. retail price (does not apply to products manufactured after the hospital's request).
23. the labelling of medicinal products produced in Pharmacies, the following specific warnings: 23.1. "shake before use" (potion and suspension)-Green letters on a white background;
23.2. "protect from light. Store at a temperature of 8 °-15 ° C "(potion, the suspensions, the flowers, the oral drops) – white letters on a blue background;
23.3. "child" (children up to the age of 14 for medicinal products) – black letters on a green background;
23.4. "use carefully!" (medicinal products containing narcotic substance, atropine sulphate, silver nitrate, arsēnpaskāb anhydride, sodium arsenāt, dikaīn, ephedrine, pseudo, St.Johns, triheksifenidil) – red letters on a white background;
14.6. "keep away from fire!" (medicinal products containing flammable or explosive substances) – white letters on a red background.
24. The Pharmacy made the labelling of the medicinal product, the following are captions and signālkrās: 24.1. oral medications-green signālkrās "oral" in white letters;
24.2. medicines used topically-Orange signālkrās "externally" in white letters;
24.3. eye drops and eye ointment, pink signālkrās "eye drops" or "FLOWER" of the eyes black.
25. This provision of the information referred to in point 22 is on the primary or secondary packaging, and it is clearly legible, comprehensible and indelible.
26. Highlighting the printed typographic or produced using computer equipment. The label affixed to the pharmaceutical primary packaging (if it does not affect the quality of the product) or secondary packaging.
Vi. Industrial Division and manufactured medicines labelling pharmacy Pharmacy, where 27 special permission (license) is indicated in the annex to the special operating conditions – drug-producing, allowed to divide industrially produced medicinal product issued for individual patient after medical treatment person's prescription and the amount of the secondary packaging which does not correspond to the quantity indicated in the recipe. The Pharmacy where special permission (license) is not listed in the annex to the special operating conditions – the manufacture of medicinal products, manufactured products allowed divided according to the recipe specified, without damaging the primary packaging of the medicinal product.
28. the issue of drugs according to paragraph 27 of these rules, the pharmacist shall ensure compliance with the labelling of the medicinal product that rule 10 requirements referred to in point, as are also the instructions for use.
29. If the patient is not registered in the Republic of Latvia issued medicines that are imported on the basis of a person's treatment to the individual patient prescription prescription in accordance with article 10 of the law on Pharmacy '' 7a '' section, the pharmacist shall inform the patient about this at the bottom of the rules mentioned in paragraph 14.4. use of medicinal products. In such a case, the provisions of paragraphs 4 and 6 of the above requirements do not apply to the drug label and instructions for use.
VII. Monitoring and control 30. If there is a change in the Republic of Latvia register of medicinal products included on the labelling of the medicinal product or in the instructions for use relating to this provision requirements, but are not associated with the changes to the summary of product characteristics, the State Agency of medicines shall submit the application to which you added the medicine of the primary and secondary packaging samples or models, as well as instructions for use. This application state agency of medicines shall examine within one month. If further information is necessary, the State Agency of medicines required by the administrative procedure law, taking into account that the final decision should be taken during 90dien after receipt of the application. If the 90dien of the lodging of an application is not received in the State Agency of medicines that it opposes the change, provided the applicant can implement changes.
31. the State Agency of medicines shall check the label text translation national language compliance with information provided on the label and instructions for use of the translation of the text of the operating instructions of the manufacturer of the medicinal product and the summary of the information provided, as well as the requirements laid down in these provisions. Check the instructions for the grant identification number.
32. expenditure linked to the drug label and instructions for use check the translations are included in the registration fee, or pay for a parallel imported medicinal product distribution authorisation laid down in the laws of the State Agency of medicines of public services price list.
33. the implementation of these provisions under the control of the pharmaceutical inspection. To verify that these rules, requirements, national pharmaceutical inspectorate and the State Agency of medicines according to the competency provides operational exchange of information.
VIII. Closing questions

34. Be declared unenforceable in the Cabinet of Ministers of 25 March 2003 Regulation No 136 "labelling of medicinal products and pharmacovigilance manual sliding requirements" (Latvian journal, 2003, nr. 49).
35. The Republic of Latvia register of medicinal products medicinal products, which included this provision at the time of the entry into force of the marketplace (released for free circulation), this paragraph 12 of the rules of such requirements may not apply until 31 December 2011.
36. The Republic of Latvia register of medicinal products medicinal products, which included this provision at the time of the entry into force of the marketplace (released for free circulation), this rule 16, paragraph requirements shall apply not later than by 1 January 2007.
37. Traditional herbal medicinal products that are on the market (released for free circulation) before the entry into force of these regulations, this provision 21 the requirements referred to in paragraph introduced by 2012 of 30 October.
38. as regards the market existing medicinal products of the Republic of Latvia register of medicinal products covered by this provision and paragraph 7.8.10, 14, 15, 17 and 19, paragraph introduces requirements to 30 October 2008.
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 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
3) 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 Editorial Note: the entry into force of the provisions by 25 January 2006.
 
Annex to the Cabinet of Ministers of 17 January 2006, regulations No 57 AIDS and information leaflet attachment 384 kb RTF Health Minister g. Smith