Distribution And Quality Control Procedures

Original Language Title: Zāļu izplatīšanas un kvalitātes kontroles kārtība

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/159645

Cabinet of Ministers Regulations No. 416 in Riga in 2007 (26 June. No 37 36) distribution and quality control procedure Issued in accordance with article 5 of the law of Pharmacy (3) and article 19 i. General questions 1. determine drug (excluding veterinary medicinal products), including homeopathic medicines and herbal medicines, distribution and quality control procedures.
2. the rules apply to drugs: 2.1 produced industrially or manufactured by a method that involves an industrial process;
2.2. prepared in a pharmacy in accordance with a medical prescription for an individual patient (the magistral formula);
2.3. What is prepared in a pharmacy in accordance with the pharmacopoeia monograph and is intended to be supplied directly to the patients served by the pharmacy in question (the officinal formula);
2.4. what person or receive by mail are imported for personal use;
2.5 2.5. received and send mailings. This also applies to countries which are not members of the European Union and European economic area countries (hereinafter third countries);
2.6. What are donated.
3. Free ports and special economic zones, customs control zones, customs warehouses and free zones in customs apply to the distribution and quality control requirements, as well as the control and monitoring measures laid down in these regulations.
4. the rules do not apply to the importation of medicinal products for human use across the customs border of the countries which are not members of the European Union and European economic area countries, and exports of medicines across the customs frontier to third countries (other than medicines imported by a natural person or receive by mail for personal use).
5. the meaning of these provisions: the suspected fault 5.1 is when the medications you receive a message that indicates that they do not have the registration specified in the quality documentation;
5.2. the quality defect product is when the entire production series of the medicinal product or its part does not meet the eligibility requirements and drugs are dangerous to the user, if it is related to the packaging of the product;
5.3. the owner is the person referred to in the regulations on the registration of the medicinal product;
5.4. the series is the withdrawal operations carried out to remove the medicine series from distribution and user network;
5.5. the medicine retail distribution of the population is from pharmacies;
5.6. wholesale of medicines are all actions that include the purchase of medicinal products, storage, supply or export, except for the supply of medicinal products to the public. These actions are implemented by the manufacturer or their branches, importers, other wholesale distributors or with pharmacies and persons authorised to supply medicinal products to the public (medical institutions, social care institutions);
5.7. the counterfeit medicine is medicine for identity or origin is with the šēj intention of misleading previously marked. Counterfeiting can apply to both the original medicinal products and generic medicines. Fake medicines may include: 5.7.1. with the correct ingredients;
5.7.2. with wrong ingredients;
5.7.3 without active ingredients;
5.7.4. with the active ingredients in insufficient quantities;
5.7.5. to simulate the packaging;
5.8. the donation of medicines are distributing medicines free of charge or at a price lower than the price of the medicinal product, taking into account the manufacturer's price, declared in accordance with the laws and regulations on drug pricing principles, as well as the maximum lieltirgotav of medicines and pharmacy mark-up, depending on which market participants medication donates.
6. the parallel import of medicinal products is a national registration procedure (also the mutual recognition procedure and decentralised procedure) for the supply of medicinal products registered in one country of the European economic area to Latvia, where they delivered medicine wholesaler who is not the manufacturer of the medicinal product, the owner of the registration of the medicinal product or his authorized representative (hereinafter referred to as the parallel importer).
7. the parallel distribution of medicinal products is centralized registration procedure for medicinal products authorised in the delivery of the European economic area country to Latvia, where they delivered medicine wholesaler who is not the manufacturer of the medicinal product, the holder of the registration or his representative (hereinafter referred to as the parallel Distributor).
8. Central Registration is registration of 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 (hereinafter referred to as the European Parliament and Council Regulation No 726/2004).
9. The illicit manufacture of narcotic drugs and psychotropic drug supplies from countries of the European economic area and the countries of the European economic area, in addition to the requirements laid down in these provisions comply with the requirements laid down in the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order".
10. Medicine gift shall meet the following requirements: 10.1 halls only medical authority donates or social care institution, subject to the requirements of the laws on the acquisition, storage, use and accounting procedures of treatment institutions and social care institutions;
10.2. medicines donates medical authorities or appropriate social care institutions in writing request. The required medicines and their quantity corresponds to the profile of the institution and the amount of work;
10.3. social care institutions only registered OTC donates medicines;
10.4. the medical authorities only registered donates drugs which are not included in the legislation for the outpatient treatment of medicinal products and medical equipment purchase expense compensation procedures in that the eligible list and medicinal drugs which are not purchased at the State or local budget resources under the public procurement Act;
10.5. the donor of the medicinal products shall ensure that patients treated with dāvinātaj drugs, treatment with these drugs can continue as long as necessary, or until such time as this medicine will be included in the list of medicinal products eligible and will be available on purchase of medicines compensation system;
10.6. the time of receipt to the medicinal drug expiration date remains not less than one year, but if the total time of use of the medicinal product shall not exceed one year, until the drug expiration date is not less than half the total time the use of the medicinal product;
10.7. medicine gift presented with invoice;

10.8. medicine donor supports the unused gift collection and disposal of medicinal products according to the movement of hazardous waste regulatory normat at vajiem.
II. Medicine wholesale requirements 11. Medication may distribute wholesale merchant, that in accordance with the laws and regulations that govern the special permit (license) the pharmaceutical activity, suspension of service, the procedure for renewal and cancellation, medicine is the National Agency issued: 11.1. special permission (license) to open the medicinal lieltirgotav (operation);
11.2. special permit (license) for the production or import of medicines, which entitles the holder of the authorization to distribute by wholesale the medicinal products of their own production, which the State Agency of medicines shall issue the special permit (licence), is included in the database according to the laws and regulations of the special permission (license), the activity in issue in the pharmaceutical, the suspension, cancellation, renewal and order;
11.3. special permission (license) to open a drugstore (operation), which is indicated in annex special operating conditions-wholesale distribution of medicinal products, medical institutions and social care institutions.
12. in paragraph 11 of these rules that a person (hereinafter referred to as the drug dealer of any longer), wholesale distribution of medicinal products, ensure that the following requirements are met: 12.1. ensure at any time the premises, facilities and equipment availability national pharmaceutical inspection officials control;
12.2. buy drugs (or receive mail) only from persons who have this provision in paragraph 11.1 or 11.2 or paragraph 13 referred to special permit (license);
12.3. the supply of medication (or send mail) only to persons who have the right to distribute the medicines wholesale or retail, or medical institutions and social care institutions, having a national pharmaceutical inspection checks issued by Act, which contains the appropriate decision on the purchase of medicinal products;
12.4. develop emergency plans, in cooperation with the manufacturer of the medicinal product concerned or the owner, or by the national pharmaceutical inspection order to ensure effective withdrawal from the market of the medicinal product;
12.5. storing protocols or packing slips (in paper form, electronically or in any other form) of purchase and sale of medicines to deal with than any of the drugs would be available the following: 12.5.1. date of the transaction;
12.5.2. name of the medicinal product;
12.5.3. received or delivered quantities of medicinal products;
12.5.4. the recipient or the supplier's name and address;
12.5.5. period of validity of the medicinal product;
12.5.6. data that ensures the identification of suppliers and recipients: 12.5.6.1. the price at which the medicine of the medicine sold to the recipient.
12.5.6.2. each of the manufacture of medicinal products supplied by serial number;
12.5.6.3. manufacturer of the medicinal product and the country of manufacture, the firm which provides information, after which you can keep track of each medicine series distribution;
12.6. ensure that rule 12.5. data referred to in point are stored and accessible national pharmaceutical inspection officials for at least five years, but with regard to narcotic and psychotropic drugs and substances-at least 10 years;
12.7. follow good distribution practice the principles and guidelines laid down in chapter III of these rules;
12.8. ensure adequate and continuous supply of medicines to pharmacies that have received a special permit (license) to open a drugstore (operation) (pharmacy), and persons authorized to supply medicinal products to ensure the needs of patients, as well as fulfilling public service obligations, of constantly guaranteeing the adequate range of medicinal products availability and any ordered quantity of medicines supplied under request in a short period of time also medicinal product withdrawn from the market place, where the distribution was stopped and the medicinal product withdrawn from the market in accordance with the provisions of section 115.1.;
12.9. two days after the request, supply pharmacies pharmacy for drugs, which is included in the list of products eligible under the legislation on medicinal products to treat the purchase of compensation arrangements.
13. To pharmaceutical wholesalers who distribute medicine in Latvia in accordance with article 25.1 of the pharmaceutical law terms (in another European economic area country issued a special permit (license) for the wholesale of medicines or pharmaceutical production/import), subject to these rules, a wholesaler of medicinal products.
14. European economic area country registered a company with home country is provided with a special permit (license) for the wholesale of medicines or pharmaceutical production/import, before the start of the wholesale of medicines in the territory of the Republic of Latvia shall notify the State Agency of medicines: 14.1. European economic area country granted the special permission (license), the grant date, number and country, the competent authority which has granted the special permission (license);
14.2. the foreign merchant affiliate company, registration number, registered in the register of companies and business address, phone and fax numbers, electronic mail address;
14.3. for good distribution practices officers name, actual address, work phone and fax numbers and other means of communication.
15. national pharmaceutical inspection in accordance with article 25.1 of the pharmaceutical law: 15.1. request from the relevant competent bodies of foreign information about company's license and the appropriate competencies for the exchange of information with foreign countries;
15.2. inform the companies on public service obligations.
16. Pharmaceutical wholesaler designate the officials responsible for public service obligations, and ensure that the officials would be available (by phone or by any other means) any time of the day, also if an emergency situation (pathogens, toxins, chemical agents or spread of suspected or confirmed, disasters, natural disasters, epidemics, including pandemic) pharmacy or hospital's urgent request.
17. lieltirgotav medicinal products shall ensure that site on the internet for easy access to information on medicinal products distributed and prices, as well as inform the State Agency of medicines of the website address.

18. Drug wholesaler notify the State Agency of medicines of the medicines marketing data (including parallel and distributed parallel imported medicinal products) for each quarter (up to 15 April, 15 July, 15 October 15 January) or for other public agencies requested period. The notification shall state the registration number, the name of the medicinal product, the volume of distributed, the price at which the medicine is sold, and consumer groups.
19. Drug wholesaler every six months (until July 31 and January 31) shall notify the State Agency of medicines of the data imported and exported quantities of the medicinal product (also applies to deliveries from the European economic area and the countries of the European economic area). The notification shall specify the data on total turnover in lats (value added tax), medicinal products marketed in Latvia lats turnover (value added tax) and the amount of the exported medicinal products in local currency.
20. at the request of the State Agency of medicines, especially in connection with the monitoring of adverse reactions of the medicinal products (pharmacovigilance) system, the owner shall submit a registration to the national agency of medicines in all the data on the volume of sales of the medicinal product and any other property (possession) existing data relating to the volume of waste.
III. Good distribution practice principles and guidelines 21. Medicine distribution process may not change medicinal properties.
22. Drug wholesaler creates a quality system to ensure that: 22.1. drugs that circulate, authorised pursuant to the European Community and the Republic of Latvia Law (registered in Latvia register of medicinal products, the centralised procedure or established in another country of the European economic area, as well as allow unregistered medicines);
22.2. the medicine storage conditions continuously observed (including trans portēšan of medicinal products), and they meet the requirements laid down by the manufacturer;
22.3. medicines not possible other product piejaukšan or mixing with other products;
22.4. the stored drug turnover takes place according to the requirements of this chapter;
22.5. medication stored in a safe and secure place;
22.6. the ordered medication delivered to the recipient in accordance with this provision, the bottom paragraph 12.8;
14.1. it is established in any product quality defect detection procedures and is designed for effective withdrawal procedure.
23. in any place of distribution of medicinal products, the merchant designate officials, which provides quality system implementation and maintenance. If that officer is not a pharmacist, or her qualifications and experience is not equivalent to the law on the production and control of medicinal products that qualified persons of qualification and experience of the person need work experience in medicine, means the receipt and distribution or become drug sales, or procurement. Personnel involved in the storage and disposal of medicines with drugs, have the appropriate experience, which guarantee the proper disposal of products or materials. The staff provides all the documentation available at the State Agency of medicines and the national pharmaceutical inspection officials to the claim.
24. The provisions referred to in paragraph 23 of the staff regularly organizes training. Training courses and the date of the Protocol.
25. The medicine orders address only to people with these rules 11.1 and 11.2 referred to special permit (license), or these rules in paragraph 13.
26. Drug wholesaler develop written procedures for processes which may affect the quality of the medicinal product or distribution operations quality: 26.1. obtaining and supply of medicinal products inspection;
26.2. the storage of the medicinal product;
26.3. cleaning and maintenance (including pest control);
26.4. the recording storage conditions;
26.5. inventory of medicines safety at the place of storage and during transport (freight);
16.5. the removal from sale of medicinal items;
16.6. recording (record), including the Protocol, the equestrian customer orders;
26.8. returning of the medicinal product in accordance with the provisions referred to in paragraph 31 of the conditions;
26.9. withdrawal of medicines.
27. a description of the procedure approved by signature and date on the quality system officer.
28. in paragraph 23 of these rules that person makes notes (Protocol) of each medicine purchase and sales operations. Logging (protocols) include data on which you can track all the important activities or events. Notes (Protocol) shall be kept for a period of five years, and they are easily available. Logging (protocols) is that the information referred to in paragraph 12.5.
29. Drug wholesaler shall ensure that the following requirements are met: 29.1. premises, facilities and equipment shall be such as to ensure proper conservation and distribution of the medicinal product. The measuring tools are calibrated and verified;
29.2. in the receipt of medicinal products shall ensure that the following requirements are met: 29.2.1. receipt of the location of the medicinal product shall be so arranged that, during unloading Hall will be protected from weather influences. The receive location is removed from storage. Check that the received the ordered medication and or packaging is damaged;
29.2.2. medications that require special storage conditions (such as narcotic drugs, drugs that require special storage temperature,-immunologicals), immediately identified and stored according to the procedures and rules in these 3 requirements;
29.3. the storage of medicinal products shall ensure that the following requirements are met: 29.3.1. medication stored according to the labelling of the medicinal product and in the instructions for use storage temperature regime, noting that: 29.3.1.1. room temperature is between + 15 ° C to + 25 ° C; 29.3.1.2; cool site is from + 8 ° C to + 15 ° C; 29.3.1.3. cold site is from + 2 ° C to + 8 ° C; 29.3.2. termolabil Hall (above or below the temperature sensitive drugs) stored in a cold room (aukstumkamer) or refrigerator by providing appropriate temperature regime and its registration.
29.3.3. light sensitive drugs stored in light-tight places (for example, tightly closed container, special container). If the product is not a special opaque packaging, they shall be kept in a dark place;
29.3.4. volatile substances and moisture sensitive substances stored tightly sealed in a cool place. Hygroscopic substances stored in this area of sa in hermetically sealed containers or plastic containers, if necessary, the container sealed and parafin.
29.3.5. colours and fragrances kept separate from other drugs and substances (for example, certain cabinets in tightly sealed packing);

29.3.6. medicinal plants and stored in a dry, Drogas well-ventilated room. Medicinal plants and their uses storing drog glass, paper or plastic packaging. Plants containing essential oils, stored in tightly sealed packing;
29.3.7. periodically monitor and record the room temperature storage of the medicinal product;
29.3.8. where medicinal products require special storage temperature (e.g., immunological preparations), the storage space shall be fitted with temperature recording devices or other items that indicated the periods when special temperature regime is maintained. Controls must be such as to ensure the maintenance of such a temperature in all parts of the place of storage;
29.3.9. ensure that the storage site should be clean, free from distracting things, dust and pests, and take appropriate precautions against the spillage of medicines, scattering or packaging defects, microbiological contamination, and contamination or mingling between;
29.3.10. ensure that stock market system work on the basis that first received the first product is distributed, as well as implement regular, periodic system checks. Products by their expiry date or from storage, stored separately from used items, it is forbidden to supply or sell;
29.3.11. If you suspect a possible contamination of the medicinal product, as well as medications with damaged packaging seals (seal) or damaged packages removed from inventory and sold, if its not immediately destroyed, stored separately so that they cannot be mistaken to confuse with other goods or to sell. If necessary, such products are disposed of in accordance with the laws and regulations on hazardous waste disposal.
30. the wholesaler of medicinal products shall ensure that the supply of the medicinal product shall meet the following requirements: 30.1. medication allowed to supply other wholesalers of medicines or the person who is entitled to distribute medicinal products to the public;
30.2. all deliveries of goods of medicinal products shall be accompanied by a document which contains: 30.2.1. delivery date;
30.2.2. quantity supplied for each medicinal product;
30.2.3.12.5.2. these provisions, 12.5.4. and 12.5.6. information referred to in paragraph (a);
30.3. If necessary, medicine wholesaler regularly ordered products supplied to pharmacies and persons authorised to distribute, grass as short as possible;
18.9. the medicinal product in such a way as to not lose their identification: 30.4.1.;
30.4.2. they do not pollute and do not mix with other products or materials;
30.4.3. be protected against spillage, scattering, packaging damage or theft;
30.4.4. they should be in a secure place (not at risk) and would not be subject to the appropriate temperature, light, moisture or other adverse effects, as well as to be protected against microbiological pollution and pests;
5. medicinal products in storage requires special temperature controlled, transported, pursuant to this rule in certain 29.3.8 requirements;
30.6. the person who transported the medication (commercial carriers), take the necessary precautions, šamo to the vehicle is not used for illegal carriage of medicinal products, and inform the law enforcement agencies if it is suspected that the vehicle is used illegally.
31. the conditions for the return of the medicinal product: 31.1. no quality defect, if the medicinal product, its stored in such a way as to prevent the distribution of this drug again while awaiting a decision on their use;
31.2. to undo the medications that have quality defects, perform the following steps: 31.2.1. drug wholesaler shall develop written emergency plan emergency medicine and drug withdrawal the withdrawal procedure, if cancellation is not immediate, as well as designate the person responsible for the implementation and coordination of the withdrawal;
31.2.2. any withdrawal operation shall be recorded in its duration. Protocols are available for public inspection of Pharmacy;
31.2.3. recording of supply systems so that all drug delivery destinations (including other countries) can immediately identify and communicate with them;
31.2.4. where a medicinal product is withdrawn, the drug wholesaler is entitled to decide and announce the withdrawal of all medicinal products to customers or only those who have received a recalled product;
31.2.5. If the reference medicinal product or particular medicine series, according to the relevant class of quality defects shall inform them drug wholesalers, persons who have the right to distribute medicinal products to the public, and pharmacies, which is prevalent in the series. This also applies to customers in other countries, which distributed medicines wholesale;
31.2.6. medication withdrawn from the retail network in accordance with the owner of the registration or the national pharmaceutical inspection confirmed the statement;
31.2.7. refer to medicinal products marketed products from items removed immediately and stored in separate and secure location, marked with the indication "not for sale";
31.3. the fake drugs, which are found in the distribution network, stored separately from other medicinal products, in order to avoid any likelihood of confusion. They are clearly marked with special indication "not for sale" and for them the fact immediately to the opening day of registration notify the owner and the State pharmaceutical inspek tion;
19.5. product return, rejection and revocation, marked with the indication "not for sale", as well as receiving reports of counterfeit medicines in the operation in progress. Each case shall decide on the destruction of the medicinal product, it shall be documented and recorded. That decision involves the officer responsible for the wholesale of medicines quality system and, if necessary, the owner of the registration.
32. In order to monitor the implementation of the principles of good distribution and compliance, drug wholesaler take self-control and recorded in the self-control measures.
33. If the drug wholesaler wants to distribute medication in another European economic area country, his duty is in accordance with the national legislation by the competent authorities of the State to submit the request to the competent authority that the special permissions (licenses) that gives the right to drug wholesaling.
IV. Drug parallel import requirements 34. parallel import of medicinal products authorised only if the parallel importer has received the authorisation of medicinal products by the national agency of the parallel distribution of medicinal products imported in the Republic of Latvia in accordance with the requirements of this chapter and that authorisation is in force.

35. the parallel importer on their intention to launch a parallel imported medicinal product distribution in Latvia shall notify: 21.8. registration the holder (the holder of the marketing authorisation);
35.2. the State Agency of medicines;
35.3. trademarks of the medicinal product (brand) to the owner.
36. If the parallel imported medicinal products repackaged by the parallel importer, pharmaceutical trademarks (brand) the owner's request, supply to him a sample of the product have been repacked.
37. Drug trademarks (brand) the owner may not use the trademarks (brand) to prevent repackaging when: 37.1. trademarks (brand) owner's use of the mark (brand) rights relating to the marketing system which he has created to promote artificial market sharing between the Member States of the European Union;
37.2. repackaging does not affect the original product conditions adverse;
37.3. for the new packaging is specified, which product is repacked and produced by him;
37.4. repacked for distribution of the product the packaging does not cause damage to the trademark (brand), and do not damage the reputation of the owner;
37.5. trademarks (brand) I receive prior notification before the product is placed on the repacked.
38. A parallel imported medicinal product is authorised (is released for free circulation) European economic area country, from which they deliver. The parallel import of medicinal products, even if permitted by the owner of the registration reference in Latvia registered registration, for economic reasons, not related to drug safety, efficiency and quality.
39. for these rules permit referred to in paragraph 34, the parallel importer of a drug shall be submitted to the National Agency for medicinal products imported in parallel distribution permission request application (hereinafter referred to as the application) in accordance with the provisions of annex 1. Unless the medicinal product are of different shape or strength for each pharmaceutical form and strength of the submitted application.
40. the State Agency of medicines shall examine the information submitted within seven working days from the date of registration of the application, the national agency of medicinal products and shall inform the applicant in writing of the imperfect, flawed, or submit additional information. After that check the State Agency of medicines shall require from the European economic area, the competent authority of the country where the registered and assessed the parallel imported medicinal product, the following data and documents for the evaluation of medicinal products imported in parallel: 24.9. or certain medicines supplier concerned is logged and released for free circulation and registration (marketing authorization) is in force, as well as the authorization (registration) number and date of the award;
40.2. the registration owner name, legal address and place of business;
40.3. the manufacturer of the medicinal product, the firm legal and site, as well as information on whether the manufacturer's licence is in force;
40.4. medicine qualitative and quantitative composition;
25.2. the shelf life of the medicinal product and recommended storage conditions;
40.6. Description of the method of production (if there is a difference between the parallel imported medicinal products and medicinal products registered in Latvia).
41. the State Agency of medicines shall check submitted data and documents, taking account of other European economic area State of the information received, compare them with the appropriate medicines registered in Latvia and assess data. A parallel imported medicinal product shall meet the following requirements: 25.5. parallel imported medicinal product is authorised (marketing authorisation) and released for free circulation in the European economic area country, from which it is delivered;
41.2. a parallel imported medicinal product manufacturer (pārpakotāj) is a special permit (license) for the manufacture of medicinal products, and the production complies with the good manufacturing practice requirements;
41.3. parallel imported medicinal product leaflet and labelling (country Edition) corresponds to the provisions on the labelling of medicinal products and pharmacovigilance requirements laid down, the instruction manual is not misleading and provide accurate and complete information on the product's nature, composition, the therapeutic effect, use and storage;
25.7. the parallel imported medicinal product is identical to the medicinal products registered in Latvia or have only permissible differences identified in the legislation on the labelling of medicinal products and pharmacovigilance requirements laid down for the instructions. Differences should not affect the parallel imported medicinal products the therapeutic effect, pose a risk to human health or to cause misleading patients: parallel imported 41.4.1. medicinal products and medicinal products registered in Latvia is manufactured on the same production methods, which have the same active substances and therapeutic effect;
41.4.2. drug company introduced the method of use and dose corresponds to the information on the use and dose in Latvia registered registration dossier;
41.4.3. the difference (if any) the colouring agents are small (another color code);
41.4.4. the difference (s), if any (s) is, clearly indicate in the instructions for use and labelling;
25.8. parallel imported medicinal product labelling (primary or secondary) therapeutic indications or other information that has been approved by a European economic area country, but which is not approved in Latvia registered medicinal products (if any), the obscure (for example, with the label);
25.8. parallel imports the package leaflet of the medicinal product and the label parallel imported pharmaceutical distribution company of the holder of the authorization and address. This information is not clear;
25.9. parallel imported medicines repackaged according to the laws and regulations on the production and labelling of medicinal products shall be made according to the regulations on the labelling of medicinal products and pharmacovigilance requirements laid down for the instructions.
42. the State Agency of medicines shall assess the conformity of the medicinal product imported in parallel to the requirements of this chapter and shall draw up an assessment report. If you need additional testing to evaluate whether the parallel imported medicinal products and medicinal products registered in Latvia is produced using the same production methods, the State Agency of medicines shall inform in writing the applicant.
43. If a parallel imported medicinal product differs from Latvia, registered in the State Agency of medicines shall ensure solubility test (if required). Samples for testing of the medicinal product shall be submitted to the National Agency for medicinal products imported in parallel distribution permissions.

44. the parallel imported medicines the State Agency of medicines shall decide to grant the permission of parallel distribution of medicinal products imported in the Republic of Latvia (annex 2) or refuse to grant the authorization.
45. the State Agency of medicines shall decide to refuse the parallel imported medicinal product distribution authorization if: 45.1. the information provided does not meet the requirements of this chapter;
45.2. drug safety, efficiency and quality in Latvia registered distribution or distribution is prohibited has been stopped, or the product is withdrawn from the market in Latvia or in another European economic area country.
46. If a State Agency of medicines according to the Commission of 3 June 2003, Regulation (EC) no 1084/2003 concerning the examination of variations to the terms of a marketing authorisation, the competent authority of the Member State which issued for medicinal products for human use and veterinary medicinal products approved changes in the documentation for the registration of medicinal products established in Latvia in accordance with the regulations on the procedure for the registration of the medicinal product in relation to which made parallel imports, the State Agency of medicines: 46.1. writing to the parallel importer or the applicant for authorization of the approved changes to the summary of product characteristics , instructions for use, the labelling and classification of the medicinal product;
46.2. the parallel importer of a medicinal product shall be issued with the State Agency of medicines of the approved changes.
47. the registration of the medicinal product shall be submitted by the owner National Agency an application for changes to the registration documentation, inform the parallel importer of a change in the registration dossier.
48. If after this provision specified in point 41 of those submitting data changes, the parallel importer: 29.9. stop parallel distribution of medicinal products imported, if changes occurred in parallel with the marketing authorization for medicinal products imported to the country from which the medicine supplies, and submitted to the State Agency of medicines application for approval of changes in parallel to the authorisation of the imported medicinal product distribution. The application shall be accompanied by information indicating the changes. Imported in parallel distribution of medicinal products authorised to resume after the parallel importer receives medicine State agency decision on the approval of changes in parallel to the authorisation of the imported medicines distribution;
After this rule 46 48.2. paragraph data shall be submitted to the State Agency of medicines application for approval of changes in parallel to the authorisation of the imported medicinal product distribution. The application shall be accompanied by information indicating the changes. Imported in parallel distribution of medicinal products authorised to resume after the parallel importer receives medicine State agency decision on the approval of changes in parallel to the authorisation of the imported medicines distribution;
48.3. ensure appropriate changes in parallel with the imported package leaflet of the medicinal product and the labelling of medicinal products.
49. Where a change in the parallel imported medicinal products in the distribution of the property of the permit holder, he shall notify in writing the State Agency of medicines. The State Agency of medicines shall take a decision to grant a new authorisation administrative procedure law.
50. the State Agency of medicines shall establish a parallel imported medicinal product belonging to a specific group of classification according to medicinal products registered in Latvia in accordance with the laws and regulations on the classification of the medicinal product.
51. A change in the nationality of the medicinal products registered in Latvia that the classification mentioned in paragraph 50 of the group, a parallel imported medicinal product distributed under the new drug classification group, a certain medicinal products registered in Latvia.
52. The parallel importer: 52.1. upon any actions related to the supply of medicinal products from other countries of the European economic area, log or other document intended for that purpose make accurate records showing the parallel imported medicinal product, the origin of the imported medicines production serial number and quantity;
52.2. The State provides pharmaceutical and medicinal products, State inspection agency information on the parallel imported medicinal products the request by these authorities;
52.3. save the packaging materials for medicinal products if, in addition to the (pārmarķēj) medications, did not open the package;
52.4. saves one sample of each product repackaging operation (drugs, packing material, instructions for use), if, in addition to the (over highlighting) halls, open the packages (for example, to change the outer packaging or instructions for use).
53. The applicant shall bear the costs of the parallel imported medicinal product distribution authorization in accordance with the State Agency of medicines of the public paid services price list.
54. If the parallel imported medicinal product distribution permission is refused or withdrawn, this provision fee referred to in paragraph 53 shall not be refunded.
55. the State Agency of medicines shall take a decision on the parallel imported medicinal product distribution withdrawal of permission if: 55.1. the State Agency of medicines shall withdraw the registration of medicinal products registered in Latvia or the competent authority shall revoke the registration (marketing authorization) parallel imported medicinal and economic zone of the country the country of drugs, delivery due to circumstances relating to the health of the population at risk (drug safety, quality or effectiveness), or supply of medicinal products prohibited and the medicinal product withdrawn from the market;
55.2. Medicine State agency not approve the changes to the parallel imported medicinal product;
55.3. parallel to the production of the imported medicinal product does not meet the rules for the production and control of medicinal products order in certain good manufacturing practice requirements;
55.4. State Agency of medicines shall refuse registration of the parallel imported medicinal products for distribution in Latvia;
55.5. the permit holder provided incorrect information about the parallel imported medicinal product.
56. the State Agency of medicines shall take a decision on the parallel imported medicinal product distribution suspensions if: 56.1. the State Agency of medicines shall suspend the registration of the medicinal products registered in Latvia or the competent authority shall revoke the registration (marketing authorization) parallel imported medicinal and economic zone of the country the country of medicine supply, for reasons related to the risk to the health of the public or patients regarding the quality, safety or effectiveness;
56.2. the permit holder does not submit the State Agency of medicines of the data and documents about the changes or no changes implemented in accordance with the procedure laid down in these provisions;
56.3. in parallel to the production of the imported medicinal product does not meet the regulations for the production and control of medicinal products laid down in the good manufacturing practice requirements.

57. the State Agency of medicines shall adopt a decision to cancel a parallel imported medicinal product distribution licence suspension based on the application of the holder of the authorization, if the reasons for which the permit was suspended.
58. national pharmaceutical Inspectorate monitors and controls the parallel distribution of medicinal products imported.
59. the State Agency of medicines shall ensure, to the European economic area by the competent national authorities, on request, obtain information about the parallel imported medicinal product.
V. medicine parallel distribution requirements 60. Parallel distributor announces intention to centrally distribute registered medicines: 60.1. the holder of the registration (marketing authorization holder) and the National Agency for medicines, but, if the delivery is carried out on the territory of another Member State, the competent national authority;
60.2. trademarks of the medicinal product (brand) to the owner. Before the product is put on sale have been repacked, as well as the trademarks of the medicinal product (brand) the owner's request, supply to him a sample of the product have been repacked;
60.3. the European Medicines Agency in accordance with the provisions of paragraph 63 and 64.
61. Drug trademarks (brand) the owner does not use the trademark rights to prevent repackaging this provision 37. in the cases referred to in point.
62. The parallel distribution of medicinal products is allowed even if the centralised registration registered owner does not initiate the distribution of medicinal products in Latvia.
63. the parallel distributor shall submit to the European Medicines Agency, notification of a centrally registered parallel distribution of medicinal products (hereinafter referred to as the notice) to the European Medicines Agency to the prescribed form (published by the European Medicines Agency website on the internet http://www.emea.eu.int) to the European Medicines Agency to meet European Parliament and Council Regulation No 726/2004 article 57 1 of the "o" part.
64. If the European Community annex of the marketing authorisation for a medicinal product or changing data in parallel retailer in the information provided in the notification (for example, change the data on the drug pārpakotāj or parallel distributors), parallel distributors shall provide notice of a change centrally registered parallel distribution of medicinal products in the European Medicines Agency to the prescribed form (published by the European Medicines Agency website on the internet http://www.emea.eu.int). This statement must be filed, even if changes in the country in which the medicine will be distributed.
65. If the parallel distributor introduces changes to the packaging of the medicinal products authorised centrally, changes must be justified by the need to distribute medicine. Allowed to introduce the following changes: 65.1. information on the label and in the instructions for use are in the language of the country in which the medicinal product placed on the market, and that information is identical in all the label and in the instructions for use the languages used;
65.2. packaging size changes ensure that the proposed packaging is included in the European Community the marketing authorisation of the medicinal product concerned on the centralised procedure for the registration of the medicinal product.
66. national pharmaceutical inspection to monitor and control the parallel distribution of medicinal products meet the European Community marketing authorisations for medicinal products laid down in the annexes (marking, instructions for use and the identification of the series) and meet the European Medicines Agency's statement, given the parallel Distributor notification provided by the completion of the inspection.
Vi. Specific requirements for the distribution of medicinal products in pharmacies 67. Pharmacy (pharmaceutical retailer) the distribution of medicinal products shall ensure that rule 12.1, 12.2, 12.4, 12.5, 12.6., 22.1 22.2 22.3.,.,.,., 22.5, 22.6 14.1, 29.2 29.3 29.1.,.,.,.,., and 19.5 29.4 19.4. the requirements referred to in point.
68. Drugstore allowed to purchase medicinal plants (drog) from the public and distribute the population if the pharmacy manager is checked the shop medicinal plants (drog) and found it in compliance with the description of the authorized pharmacopoeia monographs as well as if the pharmacy manager is a known medicinal plant harvesting and preparation conditions of drog.
69. Unregistered medicines the pharmacy may be issued only to the medical or veterinary prescription, which according to the legislation on prescription.
70. the medicinal products issued pursuant to the quantity specified in the recipe. If the parallel imported medicinal product differs from Latvia registered medicines, the pharmacy, the issuing of that parallel imported medicinal product, inform patients and physicians (over the phone) about the difference between parallel imported medicinal products and medicinal products.
71. If the medicine is not a pharmacy, the Pharmacy at the patient, the medical authorities or social care authority the same day the necessary medications ordered this provision in paragraph 11.1 and 11.2, or referred to in paragraph 13. After the receipt of the pharmacy medicinal product shall immediately deliver the medication treatment or social care institution or to notify patients of their receipt which the medicinal product is ordered.
72. If the recipe not registered medicinal products prescription and pharmacy drug inventory, not pharmacy: 72.1. adopted and recorded the recipe or treatment services;
72.2. contact 11. these provisions or persons referred to in paragraph 13 of the unregistered drug delivery;
72.3. draw up a request to receive unauthorised medicinal product, showing the patient name, prescription number, prescription drugs, the quantity and the manufacturer of the medicinal product (if one is specified) and passes the request for recipes or medical authority, medicine wholesaler. Recipe store pharmacy.
73. on the issue of prescription medicines (other than the usual recipe, prescription medicines that allowed to issue again), as well as medical institutions and social care institution requests remain in the pharmacy.
74. A pharmacy according to the legislation on illicit traffic in narcotic drugs and psychotropic drug distribution is recorded to the illicit manufacture of narcotic drugs and psychotropic medicines recognized as mandatory for the manufacture of the medicinal product in the journal for substances and medicines, which contain the following substances: 74.1. atropine sulphate;
74.2. silver nitrate;
46.2. arsēnpaskāb anhydride;
74.4. crystalline sodium arsenate;
tetrakaīn of the hidrogenhlorīd of 46.3. (dikaīn);
74.6. tramadol.
75. Medical treatment and social care institutions for issuing pharmacy medicinal applications stores within three years. The trade mark for this rule spend 74. substance and referred to the movement of medicinal products shall be drawn up, stores and reports according to the legislation on illicit traffic in narcotic drugs and psychotropic medicine movement.

76. special permission (license) to open a drugstore (operation), the holder shall provide the State Agency of medicines of the medicines marketing data for the previous calendar year to the next year's February 20. The notification shall specify the product number, common name of the medicinal product, the medicinal product of the price at which the medicine is sold, and consumer groups.
77. the distribution of marketing (sales) in vending machines is forbidden.
VII. Drug distribution conditions remaining item after confirmation of the change registration documentation 78. after changes in the registration dossier approved according to regulations in the Act on the registration of the medicinal product, provided the registration holder is entitled to 12 months of the decision on the change of the date of approval of the placing on the market of the medicinal products in stock that are not implemented on the registration documentation of approved changes. This condition applies to the pharmaceutical wholesale trade. After the expiry of any remaining stocks of medicinal products authorized to distribute only from pharmacies to pharmacy medicine remaining in stock. Medications can also be applied to medical institution or social care institution to the remaining stocks of medicinal products.
79. the State Agency of medicines, deciding on the approval of changes in the documentation for the registration of medicinal products registered at the same time is entitled to decide on: 79.1.  the remaining stock of medicines distribution and set shorter or longer period than those laid down in paragraph 78 of these rules. The State Agency of medicines shall authorise the remaining stocks of medicines distribution (annex 3);
79.2. remaining stocks of medicinal products marketing and not allow the distribution of medicinal products, if the changes are not introduced in the registration dossier or if it was related to the implementation of the urgent safety restrictions or protection of public health and the safe use of the product (for example, changes in the therapeutic indications, contraindications, warnings,, obtained new information on the safe use of the medicinal product). In this case, the State Agency of medicines shall notify the owner of the registration and the national pharmaceutical inspection of the decision taken on the day of its adoption.
80. Following the adoption of the decision on the approval of changes in registration the registration holder shall ensure the implementation of changes to the labelling of the medicinal product and in the instructions for use, whilst respecting the National Medicines Agency requirements and deadlines.
81. If the owner of the registration does not re-register the medicine in accordance with the legislation on the registration of the medicinal product or medicine State Agency renewal is refused, suspended or cancelled, the State Agency of medicines has the right to determine the owner of the registration of the remaining inventory of the distribution of medicinal products, taking into account the use of the medicinal product safety and the application of this provision in paragraph 78 and 79.
82. at the request of the State Agency of medicines registration, the owner of the drug manufacturers, drug lieltirgotav, pharmacy, medical institutions and social care institutions shall notify the State Agency of medicines and the national pharmaceutical inspection on the remaining stocks of medicinal products that do not have approved of the changes introduced in the registration dossier (also applies to parallel imported and distributed in parallel distribution of medicinal products). The notification shall specify: 82.1. name of the medicinal product, the strength and the pharmaceutical form;
82.2. serial number and quantity.
VIII. dissemination of unregistered medicinal requirements 83. Unregistered medicines prescribing is entitled to check the validity of the medical care and integrity inspection quality control inspection.
84. In case of doubt or suspicion of an unauthorised medicinal product distribution, the State Agency of medicines has the right to request medical care and uptime * tīz inspection for quality control of medicinal products not registered check the validity of the discharge.
85. The doctor or medical establishment before discharge of an authorised medicinal product obtains information about the characteristics of these medicinal products, to be able to assess their therapeutic effects and safety of the patient and to ensure monitoring of their use.
86. in order to obtain permission for distribution of medicines not registered (annex 4), the European economic area country issued marketing authorization holder (owner), the applicant of the registration (if the product is in the process of registration) of medicinal products shall be submitted to the national agency in the relevant submission (annex 5).
87. before the provisions referred to in paragraph 86 of the authorization not to register the distribution of medicinal products, taking into account the considerations of public health, State Agency of medicines: 87.1. notify the holder of the registration to the European economic area country on the proposal to grant the appropriate permissions for the distribution of medicinal products in the Republic of Latvia;
87.2. Requests relevant to the European economic area to the national competent authority to submit an assessment report of the medicinal product and a copy of the existing marketing authorisation of the medicinal product concerned.
88. the distribution of medicines not registered permit holder (owner) or registration of the applicant (if the product is in the process of registration) according to the legislation on the labelling of medicinal products order shall be submitted to the State Agency of medicines of the medicines packaging with labelling and instructions for use of the national language.
89. The issue of unregistered pharmaceutical distribution authorization, the State Agency of medicines shall determine the classification of a medicinal product belonging to the group in accordance with the laws and regulations on the classification of the medicinal product.
90. the distribution of medicinal products not registered holder (owner) provides: 90.1. of pharmacovigilance in accordance with laws and regulations for pharmacovigilance;
90.2. the laws on drug advertising and comply with the requirements.
91. the State Agency of medicines shall provide the website on the internet information on medicinal products registered in accordance with the provisions of paragraph 86 of unauthorised medicinal product issued in possession of the distribution authorization, indicating the name of the medicinal product, the strength and the pharmaceutical form of medicinal products, the manufacturer and the holder of the authorization, as well as the affiliation to the prescription or non-prescription medicines.
92. the State Agency of medicines shall notify the European Commission of Latvia not medicinal products registered in accordance with the provisions of paragraph 86 of an authorised medicinal product issued authorization, distribution and prescription medicines unauthorised medicinal product distribution permit withdrawn, and indicate the holder's name or business name and address.

93. medicines not registered to deliver and distribute by wholesale the medicinal products be entitled any wholesaler who is not a registered drug distribution permit issued in accordance with the provisions of paragraph 86. If you are not a registered medicines circulate parallel importer executable requirements laid down in these provisions parallel import of medicinal products.
94. in Latvia, in the non-registered medicines wholesale distributed, if the unregistered medicines distribution permission individually assigned halls (annex 6). To get that permission, a pharmaceutical wholesaler in the State Agency of medicines shall submit the application (annex 7), which adds to the hospital or pharmacy.
95. Pharmaceutical wholesaler, who received this rule 94, paragraph does not register the distribution licence: authorisation not specified in 95.1. registered medicines circulate only in pharmacies or medical institutions;
95.2. notify the State Agency of medicines for common permission not registered medicinal products specified in the serial numbers.
96. This rule 86 and 94, paragraph the applicant the application shall be accompanied by a receipt for the payment made in accordance with the State Agency of medicines of the public paid services price list.
97. the State Agency of medicines on an unregistered drug distribution authorisation administrative procedure shall be adopted in accordance with the procedure prescribed by law.
98. the State Agency of medicines shall decide on the distribution of medicinal products not registered in the withdrawal of the authorisation, if the authorisation given in: 98.1. medications are recorded;
98.2. national agencies of medicinal products is in possession of information relating to drug safety, quality and effectiveness;
98.3. false news about the not registered medicinal products.
IX. distribution of Medicines via the internet, mail and medicine for personal use 99. Via the internet is permitted to distribute the population (in the territory of the Republic of Latvia) only non-prescription medications.
100. the distribution of medicinal products at retail through the internet only pharmacies, which are: to provide population 100.1. the clock through the internet to contact the Pharmacy and get from the free information and advice on such products in the pharmaceutical care according to the regulations of the opening and operation of pharmacies;
100.2. According to paragraph 103 of these provisions created a website that is accessible to inter State residents at any hour without a break, and the information complies with the laws and regulations on drug advertising.
101. If a pharmacy distributing the medicine retail trade through the internet, special permission (license) to open a drugstore (operation) owner provides the required server capacity and its connection to the communication channel capacity.
102. A pharmacy that distributed the medicine retail sales via the internet, to immediately provide the website on the internet updating of the information provided and inform the State Agency of medicines and the national pharmaceutical inspection on domain name, electronic mail address, as well as amendments thereto.
103. The provisions referred to in subparagraph 100.2. home page has the following structure and content: 103.1. pharmacy function and electronic communication: 103.1.1. Pharmacy Services report, with explanations about the possibility to receive the service;
103.1.2. If a service requires the application to determine the sample forms provides forms and print them from the home page (PDF or other universal formats) or fill out the website directly, as well as providing explanations of the form duly completed. If the form is filled out in several languages, the explanations also provides the relevant languages;
103.1.3. interactive elements (for example, "your question", "Pharmacy", "reply submissions, complaints," "response to submissions, complaints");
103.1.4. the ability to send a letter to the pharmacy (the application), electronically (for example, XML);
103.1.5. specified electronic mail and to send suggestions for the website;
103.2. details of Pharmacy: 103.2.1. pharmacy name, address, business hours, phone and fax numbers, special permission (license) number, special permission (license) holder's firm, address, registration number and bank details;
103.2.2. the pharmacist's name and registration number of the Latvian Association of Pharmacists who provide advice on medicines;
103.2.3. graphic additional features – pharmacy location map with an indication of the nearest public transport and special permits issued to pharmacies (license) to open a drugstore (operation) a graphical image;
103.3. website information of the last renewal date;
103.4. start page to link to, as well as the sai test to a higher level page, if the site server is a multi level structure.
104. the sending of mail is clearly identifiable. Legal person who receives the mailings or send medicine, have: this rule 104.1.11.13. special permit referred to in paragraph (license) or medical practice registration certificate of registration with the Association of Latvian doctors physicians practice in the register or a certificate of registration of the hospital's medical institutions, issued by the health statistics and medical technologies State Agency, if the medicinal product receives the medical establishment (medical practice);
104.2. a national medicines agency panels permit issued according to the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" when transferring and receiving a list II and III substances and medicines.
105. The Person who sent the drug, submit the mail service provider for instructions on shipping terms (for example, special temperature mode) and signed a contract with the postal service about ensuring compliance with instructions.
106. A natural person has the right (does not apply to the narcotic and psycho tropic medicine): 106.1. the importation or by mail to receive medications for personal use from a clearly identified the consignor of the product, which according to the law of the sending State shall have the right to distribute the medicine. Medicinal products imported or received in quantity at a time can be the equivalent of 12 months of use. The need to use prescription medications an individual showing presents recipe recipes transcript or copy of the approved by the pharmacy that the medication, or other treatment issued by the person charged;

106.2. send medicine to another country, if permitted by the law of the country where the grass sends.
X. quality control of medicinal products 107. Before distribution of medicinal products, the rules contained in annex 8 Hall be subject to quality control. 8. the annex to these provisions (4) and (5) samples of medicinal products included in submitted to the National Agency for medicinal products, except where such medicinal products are produced in series in another European economic area country and its national competent authority has previously checked the concerned medicinal product series and pledged compliance with approved specifications.
108. If necessary, the State Agency of medicines shall organise examination of samples and are entitled to admit of any other European economic area countries official medicines control laboratory testing results or, if the medicinal product is manufactured in Latvia, certifies compliance with approved specifications, based on the series production of the Protocol and the results of the analyses. Check out the administrative procedure law, but no later than 60 days after receipt of samples and documentation.
109. The medicinal product samples for testing are entitled to remove national pharmaceutical inspection, except that rule 8.4, 5 and 6 referred to cases where the samples for testing to the owner of the registration.
110. A natural person is entitled to submit a Hall of the national agency of Medicine quality control.
111. Expenses related to the drug testing of samples shall be borne by the person to whom the samples removed, or that rule 110. in the case referred to in paragraph – physical person in accordance with the State Agency of medicines of the public paid services price list.
XI. Action in emergency situations and drug withdrawal order 112. delivery of medicines and medicinal products withdrawn from the market prohibited if: 112.1. the medicinal product is harmful to the conditions of use would arise;
112.2. medicines not therapeutic effectiveness;
112.3. risk-benefit balance is not favourable for the authorized conditions of use;
112.4. its qualitative and quantitative composition is not as declared in the trācij documentation for TRK;
112.5. medicinal products or has not been carried out for control of the raw materials and the manufacturing process at an intermediate state of the control, or not performed by any other requirement or obligation relating to the special permission (license) to import/manufacture.
113. the prohibition to supply the product, or its withdrawal from the market can be attributed to the series, for which the medicinal product quality suspects.
114. the withdrawal of the Series can be partial, if medicine series removes selected specific distributors or end users.
115. the owner of the Registration shall notify the State Agency of medicines and the national pharmaceutical inspection: 115.1. any action that it takes, to stop the distribution of medicinal products, or remove the product from the market (in Latvia or any other country), and on the basis of the activity in question, if that activity is related to the action of the medicinal product or the protection of public health. Notice that the information referred to in paragraph 119;
115.2. for each found medicines quality defects according to their class in accordance with the provisions of Annex 9, where the quality defect would follow the withdrawal of the medicinal product and of the country, which received a product with a defect.
116. If there is suspicion of drug quality defects, 11 and 13 of these rules the persons referred to in paragraph national pharmaceutical inspection notice (if the notice has not been received from the owner of the registration, the manufacturer/importer of medicines or national pharmaceutical inspection). If the State Pharmacy Inspectorate information about poor quality drugs received from the population, the medical authorities or social care institutions, national pharmaceutical inspection can take a decision on the suspension of distribution of medicinal products. The notification shall specify the name of the medicinal product, strength, form, if needed, the serial number, the manufacturer and the owner of the registration (does not apply to unregistered medicinal products), as well as those from which the medicine purchased.
117. national pharmaceutical inspection, if necessary, in cooperation with * should ensure that the notification of quality defects or drug withdrawal to be published in the press and other media (such as television and radio).
118. In emergency situations, when it found that the drugs are dangerous to the life or consumer can result in a risk to the health of consumers, the Ministry of health, on the basis of the national pharmaceutical inspection report and national operational medical opinion from the Commission, shall adopt a decision and notify the same day national radio and Television Council on public communication.
119. If the decision on the suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product, the owner of the registration of the medicinal product or the manufacturer/importer shall notify the decision adopted persons the medicines is prevalent, by phone or fax, or by using other means of communication. If the decision is communicated orally, while making the statement also in written form. The notification shall specify: the name of the medicinal product 119.1., strength, form, and, if necessary, serial number, subject to notification of the suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product;
119.2. registration the owner and the manufacturer/importer;
119.3. reasons for suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product;
119.4. quality defect class (first, second, or third) and description;
the withdrawal of 119.5. degree of urgency (time in hours in which to notify the person who delivered medicine) in accordance with the provisions of paragraph 122;
119.6. withdrawal of medicines should notify all clients or only those who have received irrevocable series of medicines;
or reference from 119.7. retail network or all of the medicine market;
119.8. further action with this treatment;
119.9. procedures for medication to be sent back to the supplier of the medicinal product or the owner of the registration;
119.10. herbal collection and destruction;
119.11. procedures will be covered.
120. a Person who receives this provision in paragraph 119 or notice referred to in paragraph 126 and responsible for the suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product: 120.1. the following information shall be recorded: 120.1.1. date and time of receipt of the notification of the suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product, as well as receive (for example, by telephone, by fax, by electronic means);
120.1.2. provider (name, first name, last name, title, telephone number, fax number, e-mail address);

120.1.3. name of the medicinal products, strength, form, the serial number, the manufacturer and the owner of the registration, subject to notification of the suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product, as well as the quality of the medicinal product and the quality class of the fault fault description (annex 9);
120.1.4. about the suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product responsible person (name, surname, position);
120.1.5. the suspension of distribution of medicinal products and medicinal products from the market launch of the withdrawal date and time.
120.2. provide medicines established distribution in suspension and withdrawal of consent of the medicinal product, notifying the persons the medicines distributed, 122 of those rules specified in the notification;
120.3. inform the notifier of the withdrawn medicinal products (annex 10).
121.119. These provisions of the person referred to in paragraph 1 within 10 days after the completion of the withdrawal from the market of the medicinal product shall be submitted to the national pharmaceutical inspection report on the withdrawal of the medicinal product (annex 10). State Pharmacy Inspectorate has the right to report the submission deadline to cut, if the product of these rules reference 118. in the case referred to in paragraph.
122. If the national pharmaceutical inspection finds quality faults (annex 9), the national pharmaceutical inspection and this provision in paragraph 119 persons suspension and distribution of medicinal products medicinal products withdrawn orally (such as by phone), and writing (via fax and electronic): 122.1. four hours from finding the moment when the product is found in first class quality defect, (9.) or have found counterfeit medicines;
122.2. within 24 hours of finding the moment when the product is found in the second class quality defect (9.2;)
122.3.48 hours from the time of the finding, if the product is found in third-class quality defect (annex 9).
123. If the exported medicinal products establishes quality defects, the owner of the registration and drug wholesaler four hours after finding writing Announces product defect medicine recipient abroad and national pharmaceutical inspection.
124. the owner of a Registration, a pharmaceutical manufacturer, importer of medicines, pharmaceutical wholesaler, retailer of medicinal products, medical establishment and social care institutions shall submit the national pharmaceutical inspection notification: 124.1. for continuous operation the phone number (or other means of communication), through which you can communicate any time of the day, and the contact persons responsible for the withdrawal of the medicinal product (annex 11);
124.2. about changes to this provision the information referred to in subparagraph 124.1.-three days after the change takes place.
XII. the obligations of the competent authority and the procedure for rapid reaction 125. national pharmaceutical inspection after 115. these rules and the notification referred to in paragraph 116 or in this chapter that the rapid response of the notification submitted to the State Agency of medicines. The State Agency of medicines shall assess whether the defect notification related to drug side effects. National pharmaceutical inspection with the State Agency of medicines shall organise the communication with regard to the assessment of risks, and current events. The assessment report shall indicate the following information: 125.1. If the fault actually exists, what are the risks to human health: 125.1.1. risks to patients and separate risk group patients;
125.1.2. risk not receiving the proper treatment;
125.1.3. risk of incorrect dosing (consider the therapeutic index);
125.1.4. immediate risk and long-term risk;
125.2. the possibility that the fault really exist and appear in the drug product manufacturer;
125.3. risks to distort the national programs of various viral diseases for the control, if the vaccines fault is suspected (cross-contamination with the virus);
125.4. or potential danger to human health is to conduct such emergency measures. Negotiations with drug company evaluated and the evaluation included consideration: 125.4.1. other related reports;
125.4.2. series distribution (for example, distributed some fixed medical institutions, a common wholesale network);
125.4.3. date when the first release, and the date of the last distribution;
125.4.4. remaining stocks of medicinal products, the manufacturer of the medicinal product;
125.4.5. the possibility that other medicine series can have the same defect, and they will be distributed;
125.5. background, if there is no other drug stocks and alternative products as well as the clinical effect of supply disruption;
125.6. or required next steps and evaluation of other series of the same product or other products and or problem should continue to study;
125.7. prohibition to exercise the remaining inventory of temporary or permanent;
125.8. good manufacturing practice inspections of the need to prevent a similar situation from happening again;
125.9. or a notice of the withdrawal of medicines distributed to all or certain health care professionals, or the statement distributed on television, radio and other media and that the information disclosed by the competent authorities of the home page, press or elsewhere.
126. national pharmaceutical inspection on a case-by-case basis and in cooperation with the State Agency of medicines shall assess the seriousness of the fault, the potential harm to the consumer, the parties involved and the environment, as well as a series of possible defective distribution. Based on this provision, the assessment referred to in paragraph 125, the national pharmaceutical inspection drawn up: 126.1. notice of defects of quality/revocation (12.);
126.2. communication on further actions and actions that are not urgent, as well as information on quality defects (annex 13).
127. the quick response means to ensure an urgent response from the national transmission of the notification by the pharmaceutical inspections other state compe body sheet that withdrawal of the medication is the series initiated. In this chapter, in particular the rapid procedure does not apply to emergency response procedures in relation to drug side effects.
128. the procedure is the information transfer with the rapid withdrawal of funds for medicines, if they have a quality defect, including fake medicines that require urgent action to protect human and animal health. Transmission of information between national pharmaceutical provides inspection and: 128.1. European economic area national competent authorities;

128.2. the competent authority in the country, which is preparing to join the European Union and has signed a cooperation contract between the Medicines Agency (hereinafter referred to as CADREAC);
128.3. Pharmaceutical inspection cooperation Secretariat (hereinafter referred to as PIC/S);
128.4. European Directorate for the quality of medicines (EDQM);
128.5. the competent authority of a country with which the European Community has concluded the drug good manufacturing practice compliance assessment of mutual recognition agreement (hereinafter MRI).
129. the discharge of the procedure the national pharmaceutical inspection shall ensure at any time of day.
130. the national pharmaceutical inspection, providing a rapid response procedure: 130.1. transmits information that urgency and seriousness does not allow any delay. The procedure can be used to transmit other information in connection with the withdrawal of the precautionary or medicinal drug safety reasons or in connection with the next enforceable actions. To ensure a rapid response procedure is effective, quick response system allowed to broadcast emergency information only. National pharmaceutical inspection provides that: 130.1.1. about first class defects (9.1) sends a response message to all countries of the European economic area, CADREAC, PIC/S, the ETIC and MRI, regardless of whether the series is or is not exported to that country;
130.1.2. about the second grade defects (9.2) sends a response message to those countries of the European economic area, CADREAC, PIC/S, the ETIC and MRI, for which it is known or there is reason to believe that the series is distributed. If in the case of parallel importation can not track series for distribution, the response message sent to all the countries of the European economic area to the competent authorities;
130.2. the notice of third grade faults (9.3) not send;
130.3. If needed, give notice of the revocation or the distribution of the product the ban because of the special permission (license) for the production of medicinal products.
131. If the response message is sent to the other country's competent authority, national pharmaceutical inspection to be completed in English, accompanied by a list of medicinal products distributed and sent by fax to the recipient or, if possible, by electronic means.
132. the notification of quality defects or drug withdrawal (12) national pharmaceutical inspection programme: 132.1. for first class defects (also applies to data transmission in the rapid alert system) four hours from the time of the finding. In addition to the rapid dispatch of fax communication is also provided at the phone number listed on the vehicle outside working hours;
132.2. for second grade defects within 12 hours of the finding. The rapid alert system for the notification of national pharmaceutical inspection be transmitted no later than 24 hours from the time of transmission of the communication at the national level;
132.3. the third class of fault 48 hours from the time of the finding. Emergency response procedures in national pharmaceutical inspection need not be provided.
133. the national pharmaceutical inspection: 133.1. develop such internal regulations: 133.1.1. arrangements for receiving response message;
133.1.2. procedures evaluated rapid communication;
133.1.3. procedures for the issue of the rapid notification and send: 133.1.3.1. persons who are included in the European Medicines Agency's response in the list;
133.1.3.2. third countries with which Latvia has concluded bilateral cooperation agreements in the health sector (competent authorities);
133.1.3.3. drug dealers and users in the Republic of Latvia;
133.1.4. procedures for the quick response issued the notice on further actions, and dissemination of information on quality defects that is not urgent (annex 13);
133.2. order of officials responsible for the rapid transmission of the notification and shall notify the European Medicines Agency, stating the officer's name, surname and contact types during and outside working time and shall notify the European Medicines Agency on changes to these data;
133.3. the owner of the registration of the medicinal product helping the recall process and supervise the withdrawal process of medicinal effectiveness;
133.4. ensure that information on drug withdrawal as soon as possible notify this rule 128. persons referred to in paragraph 1, if the quality defect poses a serious risk to public health;
monitored drug withdrawal 133.5. process control;
133.6. the study conditions, which distributed the product with quality defects, and shall ensure that the manufacturer of the medicinal product and, if necessary, also the owner of the registration, make any necessary corrective action;
133.7. next steps that are not urgent, and information on quality defects shall be given in respect of this provision in annex 13.
134. national pharmaceutical inspection on a case-by-case basis and in cooperation with the State Agency of medicines shall assess the seriousness of the fault, the potential harm to the consumer, the parties involved and the environment, and the possible defective series.
135. Where medicinal products with quality defects (also applies to parallel imported medicinal products and medicinal products distributed in parallel) originally found in Latvia, the national pharmaceutical inspection with the State Agency of medicines: 135.1. the study quality defect and issue order for emergency communication (medicinal products, which are registered in the national registration procedure);
135.2. led by quality defect investigations and issued the order for rapid communication (medicinal products that have been registered in a centralized registration procedure or medicinal products that have been registered and centralised, and national registration procedures). The statement is included in the recommended steps all the competent authorities concerned.
136. national pharmaceutical inspection (in cooperation with the State Agency of medicines) may agree on the action to be taken by the European Medicines Agency and the European Medicines Agency's Committee for medicinal products medicinal products representative of the Committee's rapporteur on medicinal products.
137. the procedure of the different packaging of the medicinal products include description, which the product may be packed (if the information is received from the European Medicines Agency).
138. If parallel distribution drugs are repacked, but the fault is not related to repackaging and resulted in the production of medicinal products, the rapid notification of the different packaging of the product descriptions in which distributed (if the information is available from the European Medicines Agency).

139. The rapid response system of 128.1.2 these provisions. the States referred to in paragraph 1 below and the authorities shall also notify the fact of distribution of medicinal products by sending information about: 139.1. possible counterfeit medicines;
139.2. medicinal products which are manufactured, fraudulent packed, distributed or advertised;
139.3. products containing fake inputs.
140. the State inspection of pharmacy shall establish and maintain a system for following suspicion product with defects, ensure appropriate notification and creates, maintains and restores the undone list of the medicinal products in accordance with the summary of the European Commission of Community inspection and information exchange procedures.
141. the decision on the suspension of distribution of medicinal products, and drug withdrawal date of issue of the decision of the national pharmaceutical inspection submitted to the sanitary border inspection, the State Agency of medicines and the Health Ministry. National pharmaceutical inspection ensure and supervise the execution of the decision, including the further executable operations.
142. If the medicinal product withdrawn from the market, the owner of the registration of the medicinal product or the manufacturer of the medicinal product shall be borne by the users, as well as losses incurred expenses that people who bought the Hall in connection with the collection, conveyance of these products to the place of destruction and annihilation. If not of good quality and they removed from circulation, the above losses and expenses shall be borne by the person whose fault the halls have become noisy.
143. If the notes are not of good quality and they removed from circulation, the provisions referred to in paragraph 142 of the losses and expenses shall be borne by the person whose fault the halls have become noisy.
144. the distribution of invalid medicines disposed of as hazardous waste regulatory laws.
XIII. 145. National pharmaceutical supervision inspection: 145.1. European Parliament and Council Regulation No 726/2004 article 18 and 19 of the competent supervisory authorities of the obligations relating to the medicinal product, in accordance with that regulation established the centralised registration procedures (including the parallel distributed monitoring of medicines), and check the spread of the medicinal product compliance with European Community marketing authorisation of the medicinal product, containing the amendments which have been approved by the European Commission decision;
145.2. According to the competence of the European Commission's decision or the implementation of the restrictions adopted in accordance with European Parliament and Council Regulation No 726/2004 and the opinion of the Scientific Committee (referring to proposed conditions or restrictions regarding the safe and effective use, as laid down in European Parliament and Council Regulation No 726/2004 article 9 paragraph 4 of section "c");
145.3. notify the Sanitary border inspection of third countries exposed to poor quality and counterfeit products;
145.4. notify the World Health Organization initiated action (distribution of suspension or withdrawal from the market of the medicinal products) that can affect public health protection in third countries. A copy of the notification shall be submitted to the European Medicines Agency.
146. the State Agency of medicines: 146.1. the execution of the European Parliament and Council Regulation No 726/2004 article 18 and 19 of the competent supervisory authorities of the obligations relating to the medicinal product, in accordance with that regulation established a centralized registration procedure (including the monitoring of adverse reactions of the medicinal product) according to European Parliament and Council Regulation No 726/2004;
146.2. According to the competence of the European Commission's decision or the implementation of the restrictions adopted in accordance with European Parliament and Council Regulation No 726/2004 and the opinion of the Scientific Committee (referring to proposed conditions or restrictions regarding the safe and effective use, as laid down in European Parliament and Council Regulation No 726/2004 article 9 paragraph 4 of section "c");
notify the Sanitary border inspection 146.3.: 146.3.1. the National Agency for medicines decision taken under the legislation on the registration of the medicinal product, for the determination of Pharmaceutical product compliance in the statutory definition of a medicinal product and the product registration of medicinal products subject to a government agency, as well as specify a deadline by which the decision is enforceable;
146.3.2. on the void distribution of medicinal products not registered;
ensures consumption 146.4. analysis, compilation and publication of the results;
146.5. is entitled to issue 86 and 94 those provisions referred to in paragraph if registered in Latvia and the Latvian register of medicinal products include medicines to the patient or a particular disease for treatment or therapeutic manipulation can be used to perform because the medicines are not available in the consumer market. In this case this rule: 146.5.1.  86. paragraph 1 shall apply after the commencement of distribution of medicinal products;
146.5.2. the authorization referred to in paragraph 34 should be received within one year of the commencement of distribution of medicinal products;
146.5.3. the requirements referred to in paragraph 94 of pharmacies and medical authority, or recipes submitted for authorisation do not apply;
146.6. on the series that is not safe and high-quality or may be dangerous to human health or life, reported the national pharmaceutical inspection no later than the day after the finding.
147. If that rule 43 or 8.1, 2 and 3 in the case referred to in paragraph drug testing carried out by another testing laboratory that is accredited by the national agency "Latvian National Accreditation Bureau" to the standard LVS EN ISO/IEC 17025:2005 "testing and calibration of thorium competence labor General requirements", for which the Ministry of Economic Affairs has published a notice in the newspaper "journal", they will be obliged to (finding) to report to the State Agency of medicines of the test result.
148. the national pharmaceutical inspection puts website on the internet the following information on withdrawn products: 148.1. drug name, strength, shape, the serial number, the manufacturer of the medicinal product and the country of manufacture, the company but registered medicinal products? the registration number;
the reason for the withdrawal and 148.2. medicine description of the fault.
149. the National Agency for medicinal products placed the site on the internet: 149.1. the parallel imported medicinal products approved instructions and markings. A parallel imported medicinal product, which is different from the registered product, indicate the difference;
149.2. parallel importers and distributors in parallel;
149.3. parallel distributed the medicine;
149.4. remaining authorization for disposal of stocks of medicinal products;

149.5. lieltirgotav and pharmacovigilance of medicinal products manufacturer website addresses on the internet;
Latvian edition published 149.6. sample application this rule 63 notification referred to in paragraph about centrally registered parallel distribution of medicinal products.
150. the State Agency of medicines shall implement all necessary procedures to ensure that officers and employees, responsible and involved in decision making in connection with these rules determine the issuing of permits, as well as the relevant report preparers (Rapporteur) and experts have no financial or other interests in the pharmaceutical industry and not affected their impartiality. Such persons may, through a contract with the State Agency of medicines for a particular job, the State Agency of medicines shall be submitted in the annual statement of financial interests. Add the Declaration of contract.
151. national pharmaceutical inspectorate and the State Agency of medicines: 151.1. disclose information related to the drug dealer, commercial secrets and become known to them by ensuring compliance with these rules;
151.2. According to competency provides operational information exchange between the informed and the exchange of information with other authorities, as well as to prevent the diversion of illicit drug circulation, provides law enforcement agencies and the Ministry of Health information on the facts which become known to them.
152. in order to ensure the early exchange of information according to the requirements of this regulation, the manufacturer of the medicinal product, medicine, pharmacy, lieltirgotav treatment and social care institution is: 152.1. telephone;
152.2. fax machine (does not apply to pharmacies, medical authority (physicians practice), as well as social care institutions, which receive and send information provided by other technical means);
152.3. computer with the appropriate software (does not apply to treatment and social care institutions in which the receiving and sending of information is ensured by other technical means).
153. the registration owner: 153.1. is responsible for the direction of the market of the medicinal product. The owner of the registration may designate persons – registration of the owner of the local representative to the European economic area country, which she represented in the relevant Member State (hereinafter referred to as the agent);
153.2. legally located in the European economic area (a registered firm, the actual Central Administration or place of business);
153.3. after the State Agency of medicines has taken a decision on the registration of the medicinal product shall be submitted in writing to the national agency of communication: 153.3.1. on the actual distribution (marketing) launch date in Latvia, within the various types of packaging of the medicinal product;
153.3.2. on the product, the end of which the placing on the market of Latvia (temporarily or permanently), not later than two months before the termination of distribution of medicinal products (on the market);
153.3.3. any incident relating to the use of the product and satisfied or enforceable actions (in Latvia or in another country);
This provision provides 153.4.12.8. in compliance with the requirements;
153.5. ensure urgent with the distributable drug safety-related performance of žojum limited, established in accordance with the regulations on the registration of the medicinal product.
154. the representative of the posting does not exempt the holder from the obligation of registration laid down in this provision in paragraph 153. Representative shall ensure that provision in paragraph 20 and 153.3., 153.5 in 153.4. and obligations.
155. If a medicine manufacturer, pharmaceutical wholesaler, pharmacy, hospital or social care institution ceases operations, reorganize or eliminate it, the person in charge of the reorganisation or liquidation, the remaining items will be transferred for disposal of medicinal products to persons have the right to distribute medicinal or destroy stocks of medicinal products in accordance with this rule 144. the requirements laid down in paragraph 1 and shall submit the national pharmaceutical inspection information: 155.1. reconciliation of remaining inventory put medicines , distribution or destruction;
155.2. the inventory remaining drug use or distribution, indicating the legal persons which distribute medicine, or information about the destruction of the medicinal product and a statement that drug stocks destroyed.
156. the owner of the registration, medicine manufacturers, health care professionals and the public officials and employees of the Agency are not subject to civil or administrative liability for any consequences which result from the use of medicines that do not correspond to the registered indications, or consequences, caused by the use of unauthorised medicinal product, when such use is recommended or required by the competent authority (physicians), taking into account any possible of pathogenic agents, toxins, chemical the suspected or confirmed spread. Any of the above cases can cause harm, whether or not authorisation has been granted in the European Community or the product is registered in accordance with these rules.
XIV. Closing questions 157. Be declared unenforceable in the Cabinet of 27 February 2001, Regulation No 88 "the medicine import, export and distribution rules and drug lieltirgotav open and operational requirements" (Latvian journal, 2001, 88., no. 35, 52; 2003, 114 no; 2004, nr. 69).
158. These rules 2, 3, 4 and 6 the authorisation laid down in the annex presented to you does not apply to those licences that are issued to the date of entry into force of the provisions.
159. Up to the date of receipt of the application referred to in paragraph 11.2. special permit (license) for the production or import of medicinal products, to distribute their production of no trade in the veterinary medicinal product is authorised economic operators, which to this date of entry into force of the provisions have been issued a special permit (license): 159.1. pharmaceutical company to open the (operation);
159.2. for the production of medicinal products (repackaging and rewrapping) drug lieltirgotav;
159.3. production of medicines in pharmacies.
160. The medicine lieltirgotav, which to this date of entry into force of the provisions have been issued a special permit (license) to open a lieltirgotav for medicinal products with special conditions for the import of medicinal products in Latvia from outside the European economic area, and the National Agency for medicinal products authorised for the importation of these products in the Republic of Latvia from third countries is no longer entitled to distribute imported drugs of trade to the special permission (license) for the production or import of medicines.

161. the non-established drug distribution permit issued by the State Agency of medicines to the date of entry into force of the provisions are valid. After the volume specified in the permit for the import of medicine distribution for repeated admission authorization is not valid.
162. the parallel imported medicinal products Authorised for distribution in the Republic of Latvia, issued by the State Agency of medicines to the date of entry into force of the provisions, they are valid until the expiry date.
163. the State Agency of medicines has the right to a parallel imported medicinal product re distribution authorization, on the basis of the parallel distribution of medicinal products imported into the holder (owner) of the application. The application shall be submitted to the State Agency of medicines no later than 60 days before the parallel imported medicinal product distribution the expiry date of the authorisation. The application shall be accompanied by the information set out in annex 1.
164. remaining stocks of medicines distribution permit issued by the State Agency of medicines to the date of entry into force of the provisions shall be valid until the end of the period of validity.
165. The application for the issue of the parallel distribution of medicinal products imported in the Republic of Latvia, who filed the State Agency of medicines until the date of entry into force of the provisions to be considered valid.
166. the application for the authorisation of medicinal products not registered for distribution in the Republic of Latvia, which is submitted to the State Agency of medicines up to this date of entry into force of the provisions to be considered valid.
167. in paragraph 17 of these regulations set out the requirements by January 1, 2008.
168. The provisions laid down in paragraph 94, the requirement for the submission of the request for pharmacy medicine State Agency shall submit an authorisation of registered medicines distribution, and that rule 72.3. subparagraph shall enter into force by December 30, 2007.
169. Until 2007 December 30 this provision in paragraph 93 of the enforcement of the drug wholesaler is entitled medicine State Agency for the application of an authorised medicinal product distribution not authorization. The application shall be accompanied by the medical establishment or the request for the recipe.
170. Pharmacies that distribute drugs at retail via the internet and a home page on the internet or from new reconstructs, follow that rule 100.102.101, 103 and the requirements set out in paragraph. Other pharmacies that have set up home pages on the internet: 170.1. the month of the date of entry into force of the provisions of the State Agency of medicines and the country's pharmaceutical authorities for the domain name, electronic mail address, as well as amendments thereto;
170.2. website content is adjusted according to the requirements of the rules within five months from the date of entry into force of the provisions.
171. Medicinal products which have been registered in a centralized registration procedure (labelling and instructions for use of the Latvian language is approved in the European Union) in accordance with European Parliament and Council Regulation No 726/2004 and registered in the State Agency of medicines is also national registration procedure, national registration procedure for medicinal products authorised in the remaining inventory distribution is allowed only medical institution or social care institution to the remaining stocks of medicinal products by the end of this institution.
172. Regulations shall enter into force by 1 august 2007. 
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) Commission of 8 October 2003 Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (text with EEA relevance);
3) 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;
4) 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-Welfare Minister Minister d. Staķ is the Editorial Note: the entry into force of the provisions by 1 august 2007.
Annex 1-13 ZIP 80 kb