The Procedure For The Issue, Suspend Or Revoke The Permit In Latvia Controlled Narcotic Substances, Psychotropic Substances And Precursors Included In Lists Of Plants, Substances And Medicines For Use In Medical And Scientific Studies Or Training

Original Language Title: Kārtība, kādā izsniedz, aptur un anulē atļauju Latvijā kontrolējamo narkotisko vielu, psihotropo vielu un prekursoru sarakstos iekļauto augu, vielu un zāļu izmantošanai medicīniskiem un zinātniskiem pētījumiem vai apmācībai

Read the untranslated law here: https://www.vestnesis.lv/ta/id/91540

 
Cabinet of Ministers Regulations No. 610, Riga, 20 July 2004 (pr. No 44, 26) the procedures for issue, suspend or revoke the permit in Latvia controlled narcotic substances, psychotropic substances and precursors included in lists of plants, substances and medicines for use in medical and scientific studies 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. determines the order in which the natural or legal persons issue, suspend or revoke the permit in Latvia controlled drugs , psychotropic substances and precursors (I), (II) and (iii) list (hereinafter list) include growing plants, and medicinal substances for the production, import, export, use and storage of such quantity that does not exceed the medical and scientific studies or training required (permit) (annex 1).
2. A permit is not required when grown hemp seed and fibre.
3. licence gives you the right to grow plants included in the lists, as well as to produce, use, store and the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" in order to import or export lists of substances and medicines in quantities not exceeding medical and scientific studies or training required.
4. To provide lists of plants, substances and drug production, import, export, use and storage (movement) according to these rules and regulations for the illicit manufacture of narcotic drugs and psychotropic substances circulation, natural person shall prepare a description, but a legal person according to the working profile issue internal regulations and designated as laid down in the internal regulations in the law enforcement officer. Description and internal normative acts shall determine the detailed arrangements are provided in these rules and regulations for the illicit manufacture of narcotic drugs and psychotropic substances circulation in compliance with the requirements.
II. The issue of the permit procedure 5. To obtain permission, the person shall submit the application to the Ministry of health authorisation (annex 2).
6. the application shall be accompanied by a copy of such documents (original show): 6.1. natural persons or legal persons Passport registration certificate and bylaws;
6.2. the document with an indication of the location of the cultivation of plants included in the lists, or indoors with the description of the activities to be included in the lists of substances and medicinal products;
6.3. details of premises intended for operations with lists substances and medicines: 6.3.1 inventory file plan;
6.3.2. the document certifying the right to use the respective areas;
6.4. the provisions referred to in paragraph 4, the description or the internal normative acts.
7. The Ministry of health: 7.1 sends this rule 5 and 6 documents listed the national pharmaceutical inspection;
7.2. the law enforcement authorities require information about an individual or the responsible criminal convictions;
7.3. request the State of the patient and addictive substance user information on the national register of natural persons or officials responsible.
8. national pharmaceutical inspection after reading these rules 5 and 6 referred to the information given in the documents, or check the applicant has provided in these rules and regulations for the illicit manufacture of narcotic drugs and psychotropic substances circulation in compliance with the requirements, and prepare a report. Report: 8.1 natural persons first name, last name, ID number, address of the declared place of residence or entity name, legal address, as well as the address for which the transactions of the listed plants, substances and drugs;
8.2. test findings for lists of plants, substances and drug records and movement, as well as compliance with the documents submitted the information;
8.3. test identified deficiencies and discrepancies in the laws for the illicit manufacture of narcotic drugs and psychotropic substances circulation, as well as recommendations and terms of the deficiencies found and the prevention of non-compliance.
9. Ministry of health shall evaluate the information received and State Pharmaceutical inspection report and a decision on issuing a permit or refusal to issue a permit and notify the applicant in writing.
10. If the information received is not sufficient or there is doubt as to its truthfulness, vestige of the Ministry of health decision and notify the applicant, as well as require the additional information required or requested State Pharmacy Inspectorate for further examination.
11. The Ministry of health permit is issued for three years.
12. If, during the term of validity of the licence to the person it is necessary to amend the licence of the plant, substance or the volume and nomenclature and include plants, substances or medication from the same list, or the list that less dangerous plants, substances and medications than specified in the authorisation, the person shall submit to the Ministry of health in these rules referred to in paragraph 5. The Ministry of health, taking into account the submissions and previously submitted that rule 6, 7 and 8, the information referred to in paragraph 1 within 10 working days of the authorisation shall be issued with a validity period of the permit in the previous expiration date.
13. If, during the term of validity of the licence to the person it is necessary to amend the licence of 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 person shall submit to the Ministry of health these regulations 5 and 6 documents listed. The Ministry of health shall examine the documents submitted and take a decision in accordance with the procedure laid down in this chapter.
14. If changing this rule 5. or 6 mentioned under News, party five working days inform the Health Ministry.
III. The refusal to issue the permit, permission for the suspension and cancellation of Licences not issue 15, in the following cases: 15.1. The Ministry of health, on the basis of documents submitted by persons and national pharmaceutical inspection report, finds that the person can not provide lists of plants, substances and drug chain the order in the legislation on Narcotic Drugs and psychotropic substances circulation;
15.2. the application for authorization or the documents submitted that information is not true;
15.3. the law enforcement authorities or other competent authorities have received information that the lists included plants, substances or medications may be used unlawfully;
15.4. a physical person or officer is punished for offences relating to the illicit manufacture of narcotic drugs or psychotropic substances or precursors to circulation;
15.5. natural person or responsible officer of the State is included in the patient and addictive substance users national registry;
15.6. the national pharmaceutical inspection report important deficiencies in the lists of plants, substances and drug enforcement in the circulation.
16. to suspend or revoke the Authorization in the following cases: 16.1. are not included in the lists of substances and plant medicine movement according to the law on the illicit manufacture of narcotic drugs and psychotropic substances circulation;
16.2. not resolved within the time limit set for the national pharmaceutical inspection report noted deficiencies;
16.3. it is established that the person acquiring the plants included in the lists of substances or medicines other than those mentioned in the authorisation;
16.4. no designated officer;
16.5. the person has not been informed of the changes to the documents submitted;
16.6. to obtain permission, the person has provided false statements;
10.4. physical person or officer is convicted of committing a criminal offence or administrative offence punished for related to the illicit manufacture of narcotic drugs or psychotropic substances or precursors to circulation;
16.8. natural person or responsible officer of the State is included in the patient and addictive substance users national registry.
17. The decision on the refusal to issue a permit and the decision on the suspension or withdrawal of authorisation can appeal to the Court.
IV. obligations of the beneficiary of the authorisation and control 18. beneficiary: 18.1 provides lists of plant, and the movement of medicinal products according to the law on the illicit manufacture of narcotic drugs and psychotropic substances circulation;
18.2. ensure national pharmaceutical inspection officials the ability to control plants of the lists of substances and medicine circulation procedures and documentation;
18.3. The State Agency of medicines shall be submitted quarterly review (must be submitted within 15 working days after the end of each quarter) for lists of substances and medicinal plants.
19. national pharmaceutical inspection controls as the person to whom the permit is issued adhere to these rules and other the statutory lists of plants, substances and drug chain.
Prime Minister i. Emsis Health Minister r. Muciņš Editorial Note: the entry into force of the provisions by 24 July 2004.