The Procedure For The Issue, Suspend Or Revoke The Permit In Latvia Controlled Narcotic Substances, Psychotropic Substances And Precursors (I), (Ii) And (Iii) The List Of Substances And Medicinal Plants For Use In Medical And Veterinary Scientific Rese...

Original Language Title: Kārtība, kādā izsniedz, aptur un anulē atļauju Latvijā kontrolējamo narkotisko vielu, psihotropo vielu un prekursoru I, II un III sarakstā iekļauto augu, vielu un zāļu izmantošanai medicīniskiem un veterinārmedicīniskiem zinātniskiem pētījumiem, fizikālo

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/174330

Cabinet of Ministers Regulations No. 293 in Riga in 2008 (April 21. No 25 31) the procedure for the issue, suspend or revoke the permit in Latvia controlled narcotic substances, psychotropic substances and precursors (I), (II) and (iii) the list of plants, substances and drug use in veterinary medical and scientific studies, physical and chemical properties of the discovery or training Issued in accordance with the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 7 i. General questions 1. establish procedures that issue, suspend or revoke the permit in Latvia controlled narcotic substances, psychotropic substances and precursors (I), (II) and (iii) list (list I, II and III), the plant substance and drug use in veterinary medical and scientific studies, physical and chemical properties of the discovery or training I, II and III substances included on the list and the movement of medicinal products, or I, II, and III list growing plants (hereinafter permit) (1. at law) as well as the requirements, compliance with which shall be ensured by the beneficiary of the authorisation, purchasing, using, storing, tracking and destroying the list I, II and III contained in plants, substances and drugs in cases where the person in (I), (II) and (iii) list includes plants, substances and medicines necessary veterinary medical and scientific studies, physical and chemical properties as well as training. 2. a Person who wishes to obtain a permit (hereinafter applicant): 2.1 develop and approve internal regulations or equivalent document, which according to the profile and structure of the work determines the detailed procedure for implementing these provisions;
2.2. designate the officials responsible for the use I, II and III of the list of substances and medicinal plants, as well as intermediate products, mixtures and residues which are not to be used in the composition of the list I, II and III substances (hereinafter referred to as the products), the receipt, purchase, use, storage, and disposal (movement) enforcement (hereinafter referred to as the designated officer) and, if necessary, also the responsible departments;
2.3. designate at least one official entitled to list I, II and III substances, medicines and products officers absence. 3. The applicant shall ensure that his action are: 3.1 the premises, installations and equipment, to ensure (I), (II) and (iii) the list of plants, substances and products according to these rules and regulations for the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products, to (I), (II) and (iii) list includes plants, substances and medicines do not get illegal circulation;
3.2. the provisions referred to in paragraph 2.2 of the officer. II. procedure for authorization 4. Authorisation of medicinal products, the applicant State Agency (hereinafter the Agency) the application for authorisation shall be submitted (hereinafter application) (annex 2). 5. the application shall be accompanied by the following documents or copies of documents (the original show): 5.1 this provision referred to in paragraph 2;
5.2. documentation on the location of the action I, II and III the listed plants, substances, medicines and products: 5.2.1 the room inventory file plan, which provide for action I, II and III the listed plants and medicinal substances or products;
5.2.2. the document certifying the applicant's right to use the land or premises on which is expected to take action on the I, II, and III the listed plants, substances, medicines and products;
5.3. the written declaration of the applicant that the applicant (if the applicant is a sole proprietor) responsible person and not suffering from mental illness, alcohol, narcotic, psychotropic or toxic substances. 6. the Agency shall register the application and within five working days after the application and the information provided in the documents sent to the application of the evaluation and any accompanying documents to the health authorities. 7. the Agency shall ensure that the register of Fines that the applicant and the other "for the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 11, paragraph 2, that person is not punished for a criminal offence, as well as administratively punished for offences relating to the illicit manufacture of narcotic drugs and psychotropic substances and precursors. 8. the health inspectorate within 10 working days of the submission and receipt of the documents attached to it, a check shall be made to ensure that the applicant according to the job profile and the structure can ensure these rules and other regulations for the illicit manufacture of narcotic drugs and psychotropic substances circulation, as well as on the application and the documents attached thereto, in compliance with the information given in the actual circumstances. 9. the provisions of paragraph 8 Of the check referred to in the health inspection officials presented checks of acts in triplicate. One copy shall be issued to the applicant, the other copy stays in health inspection, the third copy within three days, send to the Agency. The Act of signature verification inspection of health officials who carried out the inspection, and that rule 10.9. referred to a person who attended the examination and verification of right Act to record notes about the inspection process. 10. Inspection Act: 10.1. name of applicant (individual merchant – also the name, surname and personal code), the registration number of the commercial register (national regulatory authority-fiscal code), the legal address and the address of the place where the I, II and III of the list of substances, medicinal plants and products, and the date of the check;
10.2. inspection activities and findings;
10.3. the information and documents submitted in relation to the findings and conclusions;
10.4. compliance with these rules and other regulations for the illicit manufacture of narcotic drugs and psycho tropic substances circulation requirements. In case of discrepancy in these regulations or other regulations for the illicit manufacture of narcotic drugs and psychotropic substances within the requirements of the relevant regulatory acts, part, or section;
10.5. the date when the previous check (if you have);
10.6. information on previous examination found the gap (if there were);
10.7. information concerning irregularities detected and prevented deficiencies (if any) and their prevention;
10.8. a proposal for authorisation or a suspension, or cancellation;
10.9. the applicant or the responsible (or other officer empowered to participate in the test), the name and job title;

10.10. the health inspection officer name and position, which carried out the inspection. 11. the Agency shall evaluate these rules (4) and (5) the documents referred to in this provision as well as referred to in paragraph 7 and the health inspectorate checks the information contained in the Act and shall take a decision on the authorisation or refusal to issue the permit, as well as the suspension of a permit according to this provision, 10.8. 12. If the submitted information is not sufficient or there is doubt as to its veracity, the Agency is entitled to: 12.1. to request the applicant to the additional information required;
12.2. to ask the health inspection of supplementary verification;
12.3. to call on the pharmaceutical, veterinārfarmācij, chemistry, biochemistry, or scientific institutions in the field experts with appropriate qualifications to assess the submitted information and annexes I, II and III of the list of substances, medicinal plant, and product use and validity;
12.4. to request information from pharmaceutical, veterinārfarmācij, chemistry or biochemistry with specialized knowledge or non-governmental organizations. 13. the Agency's permit is issued for an indefinite period. The Agency shall issue authorisations or re-registered permission (permit with that rule 14 and 17 amendments referred to in paragraph) then when the applicant presented the document on payment of the public under the Agency's paid service price list. If I, II and III list includes plants, substances, medicines or products required for the function of the national regulatory authority, the fee for the issue and renewal of authorisation shall not be collected. 14. If the person who has received permission (hereinafter referred to as the holder), it is necessary to modify the permission specified in (I), (II) and (iii) the list of plants, substances or medicinal nomenclature and include plants, substances or medication from the same list, or the list that less dangerous plants, substances or drugs, than specified in the authorisation, the authorisation-holder shall submit to the Agency in these rules referred to in paragraph 4. The application of this provision is added to paragraph 5 of the mentioned documents, if they are changed. The Agency, after evaluation of the information submitted shall decide on the renewal of authorisation or refusal of permission to reregister. 15. If the licence holder is required to amend the authorization specified in list I, II and III in the plant, substance or drug nomenclature and include plants, substances or medicinal products from the list in which the dangerous plants, substances and medications than specified in the authorisation, the authorisation-holder shall submit to the Agency in these rules referred to in paragraph 4. The application of this provision is added to paragraph 5 of the mentioned documents, if they are changed. The Agency shall examine the documents submitted and take a decision on the authorisation or refusal to issue a permit in accordance with the procedure laid down in this chapter. 16. If changes are made to this rule in the documents referred to in paragraph 5, the holder of the permit within five working days submit to the agency information about changes in these documents. 17. If the rules referred to in point 16 of the changes apply to the documents submitted the information indicated on the licence, the Agency shall also permission. III. The refusal to issue the permit, permission for the suspension and cancellation of the decision on the refusal to issue a licence, the Agency shall adopt, if: 18.1. based on this rule 4 and 5 in point doc ments and health inspection inspection finds that the applicant is unable to provide (I), (II) and (iii) the list of plants, substances or medicinal products according to the requirements of these regulations;
18.2. This provision (4) and (5) the documents referred to in the information included does not correspond to actual conditions;
18.3. received opinion from this rule 12.3. the experts referred to in that (I), (II) and (iii) the list of substances and medicinal plants, are not necessary and justified;
18.4. the applicant or any of the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 11 paragraph 2 such persons is punished for a criminal offence or is administratively punished for offences relating to the illicit manufacture of narcotic drugs and psychotropic substances and precursors of movement;
18.5. the applicant or the designated officer is included in the State of the patient and addictive substance users national registry. 19. the decision on the suspension of the permit, the Agency accepted if: 19.1. the authorisation holder does not provide (I), (II) and (iii) the list of plants, substances and products according to these rules and other regulations for the illicit manufacture of narcotic drugs and psychotropic substances circulation;
19.2. the holder of the authorization is not commanded by the officer;
19.3. the holder of the authorization is not informed about the changes in the documents submitted. 20. the decision on the withdrawal of the authorisation, if the Agency takes: 20.1. the application or the documents submitted that information or data does not match the actual conditions;
20.2. the health inspection of the emergency (unplanned) examination found that the holder of the relevant licence violated these rules or other regulations for the illicit manufacture of narcotic drugs and psychotropic substances circulation requirements I, II and III of the list of substances, medicinal plants, and products;
20.3. not remedied within the time limit set for the health inspection inspection shows deficiencies;
20.4. the holder of the authorization or any of the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 11 paragraph 2 such persons is punished for a criminal offence or is administratively punished for offences relating to the illicit manufacture of narcotic drugs and psychotropic substances and precursors of movement;
20.5. the holder of the authorization or the designated officer is included in the State of the patient and addictive substance users national registry;

20.6. it is established that the holder of the purchased and used (I), (II) and (iii) the list contained in plants, substances, medicinal products or products that are not mentioned in the permit. IV. Annexes I, II and III, the plants on the list of substances, and product purchasing and receiving 21. Annexes I, II and III listed plants, substances, and products of the permit holder is entitled to purchase only from a person who has received the appropriate special permission (license) or the activity in pharmaceutical veterinārfarmaceitisk or permission (I), (II) and (iii) the list of substances and medicinal plants for use in medical and veterinary scientific research physical and chemical properties of the discovery or training. 22. the responsible officer provides (I), (II) and (iii) the list of substances, medicinal plant, and product demand, packing slip-invoice and the acceptance of the transfer and presentation and storage separately from other substances, medicinal plant, and product requests, deliveries, invoices and transfer-acceptance. 23. Annexes I, II and III listed plants, substances and products are eligible to receive only the designated officer or the provisions referred to in point 2.3. 24. I, II and III of the list of substances, medicinal plant, and product requests, invoice and packing slip-transfer and acceptance the laws for 10 years. V. I, II and III, the plants on the list of substances, drugs and the use of products, accounts and storage 25. Annexes I, II and III listed plants, substances and products used only in the application for that purpose. 26. data on (I), (II) and (iii) the list of substances, medicinal plant, and product purchasing, receiving, put the issue to another person or unit officer working days recorded during the I, II and III list of plants, substances and drug mandatory log (hereinafter mandatory magazine) (annex 3), which pages are numbered and cauršūt. Mandatory log records the movement of the product. Mandatory log by the officers signature and personal stamp (if applicable) and the stamp of the holder of the authorization. Mandatory log on the last page, indicates the date on which the first and last record. 27. entries in the journal shall be made mandatory in accordance with the rules referred to in paragraph 2.1. bottom of the procedures laid down in the document. If the entry is incorrect, it is deleted so that you can see the initial contents of the entry, next to the correct entry, shall indicate the date when the correction, and the record shall be attested by the signature and the responsible personal stamp (if applicable). 28. the officer once a month, compares the mandatory log of the plants, substances, and products of medicinal residue with actual plants, substances, and product residue, and the results of the checks carried out strict accounting journal entries, indicates the date of the check and record certified by signature and personal stamp (if applicable). 29. the mandatory log after the last entry and documentation relating to (I), (II) and (iii) the list of plants, substances, and products of the medicinal product, shall be kept for at least 10 years. 30. I, II and III of the list of substances, medicinal plant, and product losses are allowed up to 0.5% of plants, substances used, the quantities of products and medicines. Loss provisions apply only where it is established by actual plant, substance or medicinal product shortage. 31. the competent authority shall draw up a law on the I, II and II found in the list of substances, medicinal plants, and the actual product loss and take the mandatory entry in the journal, in accordance with the provisions of paragraph 26. Officer and the holder of the signature Act and confirm with a personal stamp (if applicable). 32. the health inspection, carried out a check on the I, II and III of the list of substances, medicinal plant, and product order of movement, mandatory log on the last page, indicates the date of the check. Record with the signature and stamp of certifying personal health inspection official. 33. Where stored in list I, II and III contained in plants, substances, medicines and products, provides access to unauthorised persons and looting. Storage of the substance in the labelling or package leaflet of the medicinal product under certain storage conditions. 34. in the lists I and II, substances, medicines and products stored in a metal cupboard, fixed to the wall or floor, or safe, or in a separate room. Safe deposit box or metal wardrobe shall be fitted with sound or light alarm and placed in a room secured against unauthorised access to it. If included in the lists I and II, substances, medicines and products in a separate space, the space shall be equipped with an alarm that is connected to the centralised security network. 35. the holder of the authorization, this provision 2.1. bottom of the document referred to in paragraph 1 shall fix: 21.8. persons who have the right to enter this rule 33. or 34 rooms mentioned in paragraph;
35.2. procedure room or closet, or the metal safe deposit box locks, sealing the end of workdays, or sealed and turn on the alarm;

35.3. key storage. 36. (iii) the list of substances and products stored in lockers cabinets separate from other substances, medicines and products. 37. moving (I), (II) and (iii) the list contained in the plants, substances and products between the holder of the authorisation, the authorisation-holder departments ensure adequate security measures to the plants, substances and products would not be possible to steal or plunder. The necessary security measures (I), (II) and (iii) the list of substances, medicinal plants, and the movement of products between the departments of the holder of the authorization, the holder of the authorisation shall determine the rules referred to in paragraph 2.1 below document. Vi. Quality I, II and III of the list of substances, medicinal plant, and product destruction 38. Annexes I, II and III au gus, listed substances, medicines and products whose quality does not correspond to the intended activities (hereinafter referred to as the low quality products), to their destruction or transfer back to the supplier in a separate space, separated space or package, eliminating the possibility of confusion with the quality I, II, and III the listed plants , substances, medicines and products. Quality products not stored in accordance with the provisions of article 33, 34 and 36 to the requirements. 39. without quality products which are not released back to the supplier, destroyed the holder of the authorisation, the Commission established a minimum of three persons, in accordance with the regulations on hazardous waste requirements or the contract for the management of hazardous waste shall be awarded to the person who will manage hazardous waste and has received appropriate permission. On the quality of the products to return to the supplier or the transfer of hazardous waste management, the Commission draws up the transfer and adoption of legislation. 40. The rules referred to in paragraph 39, the Commission shall draw up a law on quality product destruction or surrender and acceptance report indicating the cause of the destruction, the name of the medicinal product, the serial number, quantity, the quantity of a substance listed or the quantity of product in the product lists the substances included in the percentage and total quantity, the members of the Commission of the name and job title. Legislation drawn up in two copies, signed by all the members of the Commission. One copy within three working days, send to the health authorities. The Act to be kept for at least five years. 41. On the destruction of products not made of quality record mandatory log and specify the certificate of unserviceability, or surrender and acceptance report number. VII. Annexes I, II and III, the plants on the list of substances and products shortage 42. If found (I), (II) and (iii) the list of plants, substances, medication or product shortage or surplus, happened in a criminal offence or if the damages are due to force majeure, space, metal cupboard or safe deposit box sealed and secured against unauthorised access. The holder of the authorization or the designated officer of the incident without delay to the national police (exception-loss due to force majeure) and health authorities. 43. following this provision, paragraph 42 fact finding, the holder of the authorisation shall forthwith establish a Commission composed of at least three people. Panelists include: 43.1. the holder of the authorisation or his authorized officer;
43.2. the officials responsible. 44. The provisions referred to in paragraph 43 of the Commission by a representative of the health inspectorate and the national police representative (if the crime occurred) Act shall be drawn up on the I, II and III, the plants on the list of substances or medicinal products shortage or surplus. The Act specifies the Act of dialing location and date, members of the Commission of the name and job title, plant, substance, and the name of the medicinal product, (I), (II) and (iii) the list of substances included in percentage and the total quantity (drugs in addition to indicate the pharmaceutical form, strength of the medicinal product, the production serial number, manufacturer, medicinal products contained in the products in list I, II and III substances percentage and total quantity). Legislation signed by all the members of the Commission, as well as outside the health inspection agent and national police representative (if the crime occurred). Act shall be kept for a period of five years. 45. I, II and III of the list of substances, medicinal plant, and product shortages or surpluses, theft or robbery, as well as the loss of force majeure include mandatory log and noted that rule 44 of the Act referred to in paragraph number. VIII. the obligations of the holder of the authorization and control 46. the holder of the authorization: 46.1. ensure I, II and III of the list of substances, medicinal plants and products according to these rules and regulations for the illicit manufacture of narcotic drugs and psychotropic substances circulation;
46.2. provide health inspection officials the ability to control (I), (II) and (iii) the list of substances, medicinal plants, and the procedure for the circulation of products and related documentation;
46.3. document all I, II and III, the plants on the list of substances, products and related transactions, providing the ability to control each of these activities;
46.4. the Agency shall be submitted quarterly (within 15 working days after the end of each quarter) I, II and III of the list of substances, medicinal plant, and product purchase, use, destruction and loss;
28.9. take the necessary measures to (I), (II) and (iii) list includes plants, substances, medicines and products go to the illegal circulation. 47. the health inspection controls, as the holder of the authorisation laid down in these provisions comply with (I), (II) and (iii) the list of substances, medicinal plant, and product chain: 29.3. not less frequently than once a year-if the holder of the authorization shall work with the list I and II plants, substances, medicines and products;
47.2. not less frequently than once every two years-if the holder of the authorization shall work with list III substances, medicines and products. IX. final question 48. Permits issued by the Ministry of health up to the date of entry into force of the provisions are valid until their expiration date. To receive a new permit, the permit holder shall, not later than 30 days before the expiry date of the authorisation shall submit an application to the Agency in accordance with the provisions of paragraph 4 and add this provision in paragraph 5 documents. Prime Minister i. Godmanis Health Minister i. Morris annex 1 Cabinet on 21 April 2008. Regulations No 293 Health Minister i. Morris annex 2 Cabinet 21 April 2008. Regulations No 293



Health Minister i. Morris annex 3 Cabinet 21 April 2008. Regulations No 293 I, II and III list of plants, substances and drug mandatory magazine Health Minister Morris I.