Cabinet of Ministers Regulations No. 1104 Riga 2013 (October 8. No 52 53) amendments to the Cabinet of Ministers of 18 April 2006, regulations No 304 "rules for the production and control of medicinal products order about pharmaceutical officers qualification requirements and professional experience and the order in which pharmaceutical company to issue the certificate of good manufacturing practice ' Issued in accordance with article 5 of the law on Pharmacy 3 and 13 and article 52 to make Cabinet of 18 April 2006, regulations No 304" rules for the production and control of medicinal products order for pharmaceutical officers qualification requirements and professional experience and the order in which pharmaceutical company to issue the certificate of good manufacturing practice "(Latvian journal, 2006, 70 no; 2007; 2008, 33 No 122 no) the following amendments: 1. provisions supplementing with 2.8. subparagraph by the following:" 2.8. active substances and excipients. " 2. Delete paragraph 4.1. 3. Supplement with 8.9, 8.10, 8.11..., and 8.12. subparagraph by the following: "the manufacture of the medicinal product 8.9. using only active substances, which are distributed in accordance with the wholesale market the active substance of good distribution practices. The audit examined the manufacture of the active substance in compliance with the good manufacturing practice and good distribution in the distribution compliance practice. The audit shall be carried out by the manufacturer of the medicinal product or a third party, with which the contract has been concluded; 8.10. check whether AIDS is manufactured in accordance with good manufacturing practice. Testing is documented. The test, assessing risks, taking into account the application of the quality system requirements, the source of an excipient, intended use and existing quality deficiencies identified; 8.11. checks the active substance manufacturer, importer and wholesaler of EudraGMDP registration database; 8.12. the examination of the active substances and excipients for quality and authenticity. " 4. a add to chapter II, with the 12.1 point as follows: "12.1 the manufacturer of the medicinal product shall immediately inform the health inspection and registration, if she has information that the drug, which he produced, on the basis of these provisions granted to him in paragraph 5 that the special permit (license) for the production of medicines are counterfeit, or if it is suspected that they might be fake, regardless of whether these medicines distributed by the legal supply chain or by illegal means, including the purchase of medicinal products with a Web site. "

5. Delete paragraph 30, the words ' (URwww.zva.gov.lv) ". 6. Add to the title of chapter V, after the word "medicine" with the words "and the" active substances. 7. Make the paragraph 32 as follows: "32. in order to ensure that the companies comply with the stipulated in these provisions the principles of good manufacturing practice, the State Agency of medicines shall carry out inspection, including, if necessary, unannounced inspections, to ensure that manufacturers comply with its business activities in pharmaceutical law and medicine and in the production of active substances in the field of regulatory legislation. Sample checks shall be carried out by the national agency of medicinal products in a laboratory or another European economic area national official medicines control laboratory. Inspections may be carried out in cooperation with the European Medicines Agency (inspection gets as both the exchange of information on planned and checks and inspection coordination in third countries). The State Agency of medicines: 32.1. good manufacturing practice inspections (inspections) not less frequently than every three years, drug manufacturers and not less frequently than every five years, the active substance manufacturer; 32.2. agree with drug company about when will start inspection of good manufacturing practice and shall notify in writing to the manufacturer, not later than 10 working days before the examination started (not applicable to unannounced checks); 32.3. again check the manufacturer of the medicinal product, which is located in Latvia or in third countries; 32.4. Latvia supports the existing active substance manufacturer and importer premises inspection with risk appropriate regularity and effective follow-up; 32.5. If there is reasonable suspicion of non-compliance with good manufacturing practice, shall be entitled to carry out checks in third countries existing active substances on the premises of the manufacturer or of the manufacturer or importer of the excipients in the premises; 32.6. is entitled to carry out registration of the holder of the premises licence; 32.7. is entitled to make the active substance manufacturer's test, based on the registered in Latvia, the active substance manufacturer or the manufacturer of the medicinal product in Latvia's application, which uses the relevant active substances for the production of medicinal products, if the manufacturer of the active substance is in a third country, or registered importer in Latvia or the registration application of the owner of the registered products containing the active substances concerned; 20.4. has the right to make these rules, 32.4 32.3.. and 32.6. the checks referred to by other Member State of the European Union or the European economic area, the European Commission or the European Medicines Agency's request; 32.9. is entitled to request another Member State of the European Union to make a competent authority in the third country of the manufacturer; 32.10. is entitled to make the active substances and excipients manufacturers test by the European Directorate for the quality of medicines, if the active substance or an excipient is included in the European Pharmacopoeia Monographs and has issued the certificate of compliance with the monograph of the European Pharmacopoeia requirements. " 8. Replace the words "in paragraph 33.2. sampling, also to make independent testing by the national agency of medicinal products in a laboratory or another laboratory, which has the power to take control of the quality of medicinal products" by the words "take samples in order to perform an independent test of the European economic area by an official medicines control laboratory or a laboratory of the Agency of Medicines in the country". 9. Put 36 as follows: "36. the National Agency for medicinal products authorised officials after each of these regulations 32. the checks referred to in paragraph 1 shall draw up an inspection report (annex 1) that indicates whether a drug company will comply with the good manufacturing practice requirements. The State Agency of medicines control message before confirmation within three working days following its dial sends the check to the person in the form of an electronic document, electronic mail address or, on request, in the form of a paper document and provides the possibility to submit comments. One copy of the control report sent to the drug company that has carried out a second, if necessary, shall forward to the authority that requested the verification. Where investigational medicinal product manufacturer or the importer, one copy of the control report sent to the clinical trial sponsor, ensuring confidentiality. The State Agency of medicines of the investigational medicinal product manufacturer or importer control message may be made available to the other Member States, drug clinical trial Ethics Committee or the European Medicines Agency after their reasonable request. " 10. Deleting the introductory part of paragraph 38, the words "in the month following the completion of control". 11. Make 41 as follows: "41. the State Agency of medicines: medicines tested 41.1. issue or active substance manufacturer or the importer, producer of good manufacturing practice compliance certificate (annex 2), if the Party examined complies with the good manufacturing practice requirements. The certificate is issued in the form of an electronic document, by sending them to verify the person's electronic mail address within three working days after the corresponding medicinal product or the active substance manufacturer or the importer in accordance with the State Agency of medicines supplied charge service price list has paid the prescribed fee for document assessment and inspection of good manufacturing practice. If good manufacturing practice compliance assessment related to the trip, the manufacturer of the medicinal product shall be borne by the national road Agency (transport) costs to business and back, spending on visa, spending on hotels (accommodation), health insurance and subsistence expenses in accordance with the laws and regulations on the procedures for recoverable with missions and staff travel-related expenses. Certificate paper (including duplicates) shall be issued within three working days of receipt of the request and on the service fee shall be charged in accordance with the State Agency of medicines supplied charge service price list; 41.2. If adopted this rule 38.3. decision referred, according to the regulations of the special permission (license) the pharmaceutical activities, and the cancellation of the suspension arrangements shall take a decision on the special permission (license) for the manufacture of the medicinal product suspension to control report that issue; 41.3. information about the manufacturer's good manufacturing practice certificate of compliance shall include EudraGMDP database; 25.7. enter information EudraGMDP database, if this provision is referred to in paragraph 32 inspection results show that medicinal products the active substance or excipient manufacturer does not comply with the Act and these regulations on pharmaceutical requirements and meet good manufacturing practice requirements. " 12. To complement the introductory paragraph 78 behind the words "prescribed medicines" by the words "of the active substances and excipients". 13. Add to paragraph 79 behind the words "third countries" with the words "and Latvia". 14. Replace the words "in paragraph 92 of the pharmaceutical Licensing Commission activities" with the words "the State Agency of medicines". 15. Supplement with 99.1 points as follows: "this rule 41.1. section 99.1 of the condition relating to compliance with good manufacturing practice certificate or the issue of a duplicate of the medicinal product or the manufacturer of the active substance in the form of paper documents for the fee shall enter into force on 1 July 2014." 16. Add to the informative reference to directives of the European Union with paragraph 8 by the following: ' 8) of the European Parliament and of the Council of 8 June 2011-2011/62/EU directive, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards how to prevent counterfeit medicines from entering the legal supply chain. " 17. Put 1 and 2 of the annex by the following: "1. the annex to Cabinet of Ministers of 18 April 2006, regulations No 304 good manufacturing practices inspection report No heartbeat. Product (s) and dosage form (s) name to indicate Significant inspections, carried out at the request of the European Medicines Agency, in other cases, you need only specify the specific products associated with the inspections the inspection site (s) object name and full address, including the exact proven plant location and designation. EudraGMDP reference number. Plant location identifier (DUNS number/GPS coordinates) from manufacturing operations conducted

  Medicinal products for human use veterinary medicinal product investigational medicinal products the final production: sterile products sterile products, organic products, intermediate products or medicinal products the active substance sterilization the primary packaging secondary packaging quality control checks the import Series storage and distribution certification of manufacture of the active substance in the other _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ date of inspection (s) date (s), month, year and the Inspector (s) expert (s) Tracker (s) name (s), name (s) of Experts (evaluators) name (if necessary) the responsible authority (s) (s) name (s) of the medicinal product of reference number of the registration certificate and/or special permissions (licenses) of the medicinal product production number. The European Medicines Agency reference number (s) (if the test is carried out at the request of the European Medicines Agency) in the introductory part of the business of the company and a brief description, if the examination is underway in the country, which are not members of the European economic area, indicate whether the relevant national authority was informed about the inspection and that the Authority participated in the previous inspection date inspection Inspector (s) name (s) surname (s) (s) who participated in the previous test, the major changes since the last inspection the inspection operations carried out short presentation brief inspection area inspection description (product inspection the process inspection and/or general good manufacturing practice inspections). Indicates the reason for the inspection, such as a new registration application, (routine) inspection, investigation of failure of the inspected product (s) area (s) and main inspection steps/process identifies each of the inspected areas Not inspected operations if necessary, indicate the scope or activities that were not tested during this inspection the inspection meet staff indicates the leading personnel meet the first name, last name, job title (adds the message list in the annex) observations of inspectors associated with the inspection and deficiencies found in this section can be associated with a section on the deficiencies found to explain their rankings. The description of this section can be shortened if the controlling persons recognised as acceptable body shop provided a description of chapter nosaukumiVar used to implement appropriate new chapter titles in the previous inspection Report open and the remedial measures for quality management personnel, premises and equipment, documentation, production quality control and quality control of Līgumražošan on a contractual basis, complaints and product recall Pašinspekcij distribution and transportation (shipping), for example conformity to good distribution practice questions relating to the registration of the application, such as assessment test prior to registration in specific identified Other issues such as the company reported significant changes in future shop floor the shop floor description describes the assessment, if any. Plant description date a variety of ziņasŅemt samples added to the list of annexes annex a list of Deficiencies, which are classified in the "critical", "essential" and "other" lists all the shortcomings and indicate the appropriate reference to the area of the manufacture of medicinal products regulatory laws and requirements for good manufacturing practice of medicinal products. Indicate any deficiencies identified, even if they were corrected immediately. If the deficiencies are associated with the registration of the application, evaluation, this shall be clearly indicated. Ask the company to inform the authorities about the lack of measures of prevention and of course the Inspector's comments on the responses of the manufacturer associated with the inspection of the public, for example, or the answers are acceptable to the Inspector's comments on the assessment report, the open questions/issues recommendations for future activities of the institution, after which the request of checking if the responsible authority of the country in which the tested plant summary and conclusions in the Inspector (s) indicate whether the manufacturer/importer tested in field work or fails to act in accordance with the Directive (s) 2003/94/EC and 91/412/EEC and/or requirements and or the manufacturer/importer is acceptable in relation to the specific product (this relates to situations where the non-compliance found, but agreed about the lack of prevention plans and the Inspector does not have reasonable grounds to believe, that it will not be implemented, as well as situations where there is no immediate threat to public health) name (s), name (s) signature (s) institution (s) date of report of the inspection shall be the subject of a signed and dated all inspectors/experts who participated in the inspection. If the inspection carried out by the European Medicines Agency (EMA), the inspection shall be the subject of the request to transfer the notes to the EMI. The significant lack of definition: 1. the critical weaknesses – weaknesses which are created or there is a high risk of creating products that are harmful to human or animal health, or products that leave harmful residues in animals, from which the foodstuffs of animal origin. 2. The serious shortcomings, deficiencies which are not critical deficiencies and: 2.1. which is created with the product or can be created for a product that does not meet the registration dossier; 2.2. which points to great deviations from the European Union, the principles of good manufacturing practice; 2.3. which points to great deviations from special permission (license) for the production of medicinal products conditions (within the framework of the European Union); 2.4. to indicate that adequate procedures are not carried out series of release, or (in the framework of the European Union) the qualified person does not fulfil their official duties; 2.5. the combination of various other defects, of which each individual is essential to lack, but together they can lead to significant deficiencies, therefore they must be clear and should be reported as a significant deficiency. 3. other weaknesses – weaknesses that cannot be classified as critical or important, but which indicate deviations from the principles of good manufacturing practice. Disadvantages can be classified as "other drawbacks", if they are assessed as minor, or because there is insufficient information to classify them as important or critical. 4. the document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. 2. the annex to Cabinet of Ministers of 18 April 2006, regulations No 304 of Latvia's State Agency of medicines _____ _____ _____ _____ _____ _____ _____ (address, registration number, telephone number, fax number, e-mail address) in the REPUBLIC OF Latvia, the State AGENCY OF medicines _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (address, registration number, phone, fax number, e-mail) certificate No ___/___/___ certificate Of. Manufacturer's good manufacturing practice certificate of conformity certificate OF GMP compliance OF A MANUFACTURER part 1 part 1 Issued after official verification (inspection) in accordance with the provisions of Directive 2001/83/EC article 111, paragraph 5, or Directive 2001/82/EC article 80, paragraph 5 of Directive 2001/20/EC article 15 the following an inspection Issued in accordanc with art. 111 (5) of Directive 2001/83/EC or in the 80 (5) of Directive 2001/82/EC or in Directive 15 of the 2001/20/EC or/or issued under the mutual recognition agreements between the European Union and the [mutual recognition agreement partners] Issued under the provision of the Mutual Recognition Agreement between the European Union and [MR Partner] Latvia − the competent authority of the State Agency of medicines shall certify: the Competent authority of a Member State-State Agency of medicines of the confirm the following: medicines manufacturer/the manufacturer ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ___ production site address/site address _____ ____ ____ ____ ____ ____ ____ ____ ____ Is officially tested the national monitoring and control of the programme with regard to compliance with the special permission (license) for the production of medicinal products no _____ _____ _____ in accordance with the provisions of Directive 2001/83/EC article 40 of Directive 2001/82/EC article 44//Directive 2001/20/EC article 13 *, carried in the legislation of the Republic of Latvia: Has been inspected under the national inspection programme in connection with the manufacturing authorisation. _____ _____ _____ in accordanc with art. 40 of Directive 2001/83/EC/With. 44 of the Directive 2001/82/EC/art. 13 of Directive 2001/20/EC transposed in national legislation the following: ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ _____ * or/or

Officially tested for drug registration certificate (s) of the specified manufacturers located outside the European economic area, in accordance with Regulation (EC) No 726/2004, article 8 paragraph 2/33 (2) of article/article 19 (3)/44. paragraph 3 of article or of Directive 2001/83/EC article 111 4/Directive 2001/82/EC article 80 shall be carried in the Latvian Republic legislation : Has been inspected in connection with marketing authorisation (s) listing manufacturers located outside of the European Economic area in accordanc with art. 8 (2)/33 (2)/19 (3)/44 (3) of Regulation (EC) 726/2004 or With a 113 (4) of Directive 2001/83/EC/art 80 (4) of Directive 2001/82/EC transposed in national legislation the following: ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ _____ * and/or */and/or is the producer of the active substance officially inspected in accordance with the provisions of Directive 2001/83/EC article 111/paragraph 1 of Directive 2001/82/EC article 80, paragraph 1, which takes in the legislation of the Republic of Latvia: Is an active substance manufacturer that has been inspected in accordanc with art. 111 (1) of Directive 2001/83/EC/art 80 (1) of Directive 2001/82/EC transposed in national legislation the following : _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ * and/or * excipient and/or the manufacturer, which has been tested in accordance with the provisions of Directive 2001/83/EC article 111, paragraph 1 of which engrossed in the legislation of the Republic of Latvia: Is an excipien manufacturer that has been inspected in accordanc with art. 111 (1) of Directive 2001/83/EC transposed in national legislation the following: _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ * or/or other (specify): Other (Please specify): _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ * manufacturer's official tests , the last of which was performed … …/… …/… … [date], the information obtained suggests that it comply with the good manufacturing practice requirements of mutual recognition agreements between the European Union and the [mutual recognition agreement partners]/the principles and guidelines of good manufacturing practice laid down in Directive 2003/94/EC/Directive 91/412/EEC of the active substance/principles of good manufacturing practice laid down in Directive 2001/83/EC in article 47 of Directive 2001/82/EC in article 51. Appropriate good manufacturing practice levels laid down in Directive 2001/83/EC article 46 (f). From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on .../… …/… … [date], it is considered that it would with the Good Manufacturing compl practice requirements referred to in the agreement of Mutual Recognition between the European Union and [MR partner]/The principles and guidelines of Good Manufacturing practice, put down in Directive 2003/94/EC/Directive 91/412/EEC/the principles of GMP for active substances referred to in article 47 of Directive 2001/83/EC/article 51 of Directive 2001/82/UREC.* an appropriate level of GMP as referred to in Article 46 (f) of Directive 2001/83/EC this certificate reflects the status of the place of manufacture the official checks referred to above and it cannot reflect the compliance status, if it has been more than three years since the official checks when the certificate was issued. But this period of validity may be shortened or extended by the application of risk management principles and by regulating entry restrictions and explain in the space provided. This certificate will reflect the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflec the compliance status if more than three years have elapsed since the date of that inspection, after which time the issuing authority should be consulted. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restriction or Clarifying remarks field. This certificate is valid only for full presentation of all of the pages and the two parts of the document (parts 1 and 2). This certificate is valid only when presented with all the pages and both parts 1 and 2. The authenticity of the certificate can be checked EudraGMDP database. If this database does not appear, contact the State Agency of medicines. The authenticity of this certificate may be verified in the EudraGMDP database. If it does not appear, please contact the issuing authority. Part 2 part 2 medicinal products for human use of Human medicinal products, veterinary medicinal products * Veterinary medicinal products for human use of investigational medicinal products * investigational medicinal products, Human 1. Manufacturing operations-MANUFACTURING operations of GRASS-MEDICINAL products

1.1. the Sterile pharmaceutical products formasSteril 1.1.1. Aseptically produced (production activities with the following pharmaceutical forms), Aseptically prepared (processing operations for the following "Forms) 1.1.1.1. Liquids large volume packing large volume liquid in 1.1.1.2. in Lyophilisat of the Lyophilisate 1.1.1.3. Soft dosage forms of semi-solid to Liquid in small volume 1.1.1.4. a Small volume of liquid in the package 1.1.1.5. Solid pharmaceutical forms, and implants and implant the Solid 1.1.1.6. other aseptically manufactured products (free listing) Other aseptically prepared products (free text) 1.1.2. Sterilized (production activities with the following pharmaceutical forms) Terminally sterilised (processing operations for the following "Forms) large volume Liquid 1.1.2.1. a package of large volume liquid 1.1.2.2. Soft drug in the form of semi-solid to Liquid in small volume 1.1.2.3. packaging for Small volume liquid 1.1.2.4. the pharmaceutical form and the solid implants and implant the Solid 1.1.2.5. other sterilized products (free listing) Other terminally sterilised products 1.1.3. Series certification Batch certification 1.2. Non-sterile drug formasNon-sterile products 1.2.1. pharmaceutical form sterile Not (production activities with the following pharmaceutical forms), Non-sterile products (processing operations for the following "Forms) 1.2.1.1. Hard capsules capsules, hard shell 1.2.1.2. Soft capsules capsules, soft shell 1.2.1.3. Chewing gum Chewing gums 1.2.1.4. Matrix-Matrix Impregnated Impregnated 1.2.1.5 externally usable liquid Liquid for external use 1.2.1.6. Oral liquid Liquid for internal use 1.2.1.7. Medicinal gas of medical gas 1.2.1.8 other solid dosage forms of Other solid forms 1.2.1.9." Aerosol preparations ( under pressure) of the radionuclide preparation Pressurised 1.2.1.10. generators generator 1.2.1.11. Radionuclid soft drug in form of semi-solid is a Suppositor to 1.2.1.13 1.2.1.12. Rectal. Pills tablets 1.2.1.14. Transdermal patch in Transdermal patches 1.2.1.15. Intrarumināl device Intraruminal devices 1.2.1.16. Feed additives Veterinary premix 1.2.1.17. Other non-sterile dosage forms (free listing) Other non-sterile a medicinal product (free text) 1.2.2 series certification Batch certification 1.3. Biological medicinal products zālesBiological 1.3.1. Biological medicinal products Biological medicinal products 1.3.1.1. From human blood and plasma-derived drugs Blood products Immunological preparations 1.3.1.2. Immunological products ' 1.3.1.3. Cell therapy preparations Cell therapy products 1.3.1.4. Gene therapy gene therapy products preparations 1.3.1.5. Biotechnological preparations, Biotechnology products 1.3.1.6. From human or animal materials distributed to Human or animal extracted products products created From tissue 1.3.1.7. products of Tissue engineered products 1.3.1.8. other biological medicinal products (free listing) Other biological medicinal products (free text) 1.3.2. a series of certification (drug list) Batch certification (list of product types) shall from human blood and plasma-derived drugs Blood products 1.3.2.2. Immunologicals Immunological products 1.3.2.3. Cell therapy medicinal products in Cell therapy products 1.3.2.4. Gene therapy gene therapy medicinal products 1.3.2.5. Biotechnological preparations, Biotechnology products 1.3.2.6. From human or animal materials distributed to Human or animal extracted products 1.3.2.7. the products of the tissues formed Tissue engineered products, products of the 1.3.2.8. other biological medicinal products (free listing) Other biological medicinal products (free text) 1.4. Other products or Other products of manufacturing or processing activity 1.4.1. Manufacturing: manufacture of section 1.4.1.1. Herbal Medicine Herbal products 1.4.1.2. Homeopathic Medicine Homoeopathic products 1.4.1.3. other (free listing) Other (free text) 1.4.2. Active substance/excipient/sterilization of the finished product: Sterilisation of active substance/excipient/finished product 1.4.2.1. the filter Filtration Sterilization with hot 1.4.2.2., dry air Dry heat sterilisation 1.4.2.3. steam to heat Mois 1.4.2.4. chemical sterilization Chemical 1.4.2.5. the irradiation with gamma rays the gamma irradiation Irradiation with electron 1.4.2.6. beam Electron beam 1.4.3. other (free listing) Other (free text) 1.5. IepakošanaPrimary IepakošanaPackaging 1.5.1. Primary packing 1.5.1.1. Hard capsules capsules, hard shell 1.5.1.2. Soft capsules capsules, soft shell 1.5.1.3. Chewing gum Chewing gums 1.5.1.4. Matrix-Matrix Impregnated Impregnated 1.5.1.5. Liquids should use Liquid for external use 1.5.1.6. Liquid for oral use Liquid for internal use 1.5.1.7. for medical gas Medicinal gas 1.5.1.8. Other solid dosage forms of Other solid forms "1.5.1.9. Aerosol preparations (under pressure) of the radionuclide preparation Pressurised 1.5.1.10. generators Radionuclid generator for 1.5.1.11. Soft dosage forms of semi-solid for Rectal Suppositor to 1.5.1.13 in 1.5.1.12.. Pills tablets transdermal patches 1.5.1.14. Transdermal patches 1.5.1.15. Intrarumināl device Intraruminal devices. 1.5.1.16 feed additives Veterinary premix 1.5.1.17. Other non-sterile dosage forms (free listing) Other non-sterile Office "forms (free text) 1.5.2. Secondary packaging * Secondary packing a 1.6. Quality control testēšanaQuality control testing 1.6.1. Microbiological: sterile Microbiological: 1.6.2. Microbiological sterility: not sterile dosage forms: non-sterility of Microbiological purity 1.6.3. Chemical/chemical/physical physical biological Biological 1.6.4.2. the IMPORTATION OF drug importing MEDICINAL products 2.1. The imported medicine quality control testēšanaQuality control testing of imported medicinal products 2.1.1. Microbiological: sterile Microbiological: sterility 2.1.2. Microbiological: not sterile (non-sterile dosage forms) Microbiological: non-chemical/physical sterility 2.1.3. in the Chemical/physical biological Biological 2.1.4 2.2. The imported medicine series Batch certification certification of imported medicinal products 2.2.1. Sterile pharmaceutical products formasSteril 2.2.1.1. Aseptically prepared Aseptically produced Terminally sterilised 2.2.1.2 sterilized sterile 2.2.2 pharmaceutical form of Non-sterile products 2.2.3. Biological medicinal products Biological medicinal products 2.2.3.1. From human blood and plasma-derived drugs Blood products 2.2.3.2. Immunologicals Immunological products 2.2.3.3. Cell therapy preparations Cell therapy products 2.2.3.4. Gene therapy gene therapy products preparations 2.2.3.5. Biotechnological preparations, Biotechnology Products 2.2.3.6. From human or animal materials revealed preparations Human or animal extracted products of tissues created 2.2.3.7 products of Tissue engineered products 2.2.3.8. other products of biological origin (free listing) Other biological medicinal products (free text) 2.3. Other import importation activities darbībasOther 2.3.1. the actual place of import site of physical import intermediate goods importation 2.3.2, which made further Importation of production activities which undergo further processing of intermediate 2.3.3. other (free listing) Other (free text) any limitations or explanations relating to this certificate areas: Any restriction or clarifying remarks related to the scope of this certificate:
     


3. Production activities − VIELASMANUFACTURING − active operations active substance active substance (s): active substance (s): 3.1. Chemical synthetic active substances of ražošanaManufactur active substance by chemical synthesis of active substances 3.1.1 ražošanaManufactur intermediate products of the active substance of 3.1.2. Technical intermediate (crude) production of active substances in the manufacture of the active substance of crude salts 3.1.3./purification stages: (free listing) (such as crystallization) salt formations/Purifications steps: (free text) (e.g. crystallisation) 3.1.4. Other activities (free listing) Other (free text) 3.2. Isolation of active substances from natural avotiemExtraction of active substances from natural sources 3.2.1. substances from plant avotiemExtraction of substance from a plant source 3.2.2. substances from animal sources in the Extraction of substances from animal source 3.2.3. substances from material taken from human Extraction of substances from human source 3.2.4. substances from mineral sources mineral Extraction of substances from source 3.2.5 Released substances modification (specify source 1, 2, 3, 4) Modification of extracted substance (specify source 1, 2, 3, 4) 3.2.6 released. treatment of substance (point source 1, 2, 3, 4) Purifications of extracted substance (specify source 1, 2, 3, 4) 3.2.7. other (free text) Other (free text) 3.3. The active substance of production using organic procesusManufactur of the active substance using biological processes of Fermentation the fermentation 3.3.1 3.3.2. Cell Culture (cell type) (for example, mammals/bacterial) Cell Culture (specify cell type) (e.g. mammalian/bacterial) 3.3.3. Separation/purification Isolation/modification Modification 3.3.4 3.3.5 Purifications. other (free listing) Other (free text) 3.4. The sterile active substances (respectively filling 3.1., 3.2., 3.3) manufacture of sterile active substance (section 3.1, 3.2, 3.3 to be completed as applicable) 3.4.1. Aseptically prepared sagatavotasAseptically 3.4.2 Terminally sterilised 3.5 sterilized. General final finishing steps 3.5.1. posmiGeneral physical processing stage (point) (e.g. drying, grinding, sifting, the/mikronizēšan) Physical processing steps (specify) (e.g. drying, sieving, milling/micronisation) 3.5.2. Primary packaging (inserting active substances/packaging that conclusion is in direct contact with the active substance) the Primary packaging (enclosing/sealing the active substance which is in the packaging materials within a direct contact with the substance) 3.5.3. Secondary packing (in a closed primary packaging secondary packaging insert or container. It also includes any material labelling that can be used for identification of the active substance or for traceability (serial number)) Secondary packaging (placing the primary package within an outer sealed packaging material or container. This also includes any labelling of the materials which could be used for identification or traceability (lot numbering) of the active substance) 3.5.4. Other (free text) (transactions that are not described in the preceding paragraphs) Other (free text) (for operations not described above) 3.6. Perform quality control Quality control testing 3.6.1. physical or Chemical testing Microbiological ķīmiskiPhysical/3.6.2 (except sterility tests) Microbiological testing (excluding sterility testing) 3.6.3. Microbiological (including sterility tests) Microbiological testing (including sterility testing) 3.6.4. Organic Biological testing 4. Other activities-OTHER activities of the active substance-active substances (free listing) (free text) any limitations or explanations relating to this certificate areas: Any restriction or clarifying remarks related to the scope of this certificate :
     

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The State Agency of medicines authorised officials name and parakstsNam and signature of the authorised person of the Competent Authority of United Kingdom ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ (name, title, institution, telephone and fax number/name, surname, position, national authority, phone fax number &) notes. 1. Delete the inappropriate. Delete that which does not apply.
2. This certificate applies to the importer. This certificate applies also to the importer.
3. the document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. Document property "signature" is not filled in if the document is prepared in accordanc with the law of electronic documents. " Prime Minister Valdis Dombrovskis Health Minister Ingrida Cricket»