National Pharmaceutical Inspection Rules

Original Language Title: Valsts farmācijas inspekcijas nolikums

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Cabinet of Ministers Regulations No. 232 Riga, 28 March 2006 (pr. 17. § 19) national pharmaceutical Inspection Regulations Issued pursuant to the public administration Act, article 16 of the equipment the first part i. General question 1. national pharmaceutical inspection (inspection) is the Minister of Health's direct regulatory authority, whose activities aim to ensure compliance with the legislation and supervision in the field of pharmacy.
II. Inspection functions, responsibilities and rights of inspection 2 functions are to monitor and control the production of medicinal products, the distribution of medicinal products in pharmacies, lieltirgotav, medical institutions and social care institutions, as well as the illicit manufacture of narcotic drugs and psychotropic substances to legitimate movement.
3. in order to carry out certain functions, inspection according to the competency in addition to pharmaceutical law, law on precursors "and the law" on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order "stipulated tasks performs the following tasks: 3.1 make recommendations for persons carrying out transactions with medicines;
3.2. the person doing the verification activities with drugs, narcotic and psychotropic substances and precursors, and on inspection findings;
3.3. based on the results of the inspection, provide recommendations to prevent irregularities;
3.4. the legislation in the field of pharmaceutical cases, issue administrative acts in the field of Pharmacy;
3.5. ensure medicines, including outpatient treatment of the medicinal products the price of compliance;
3.6. Control prescription order of chain pharmacies;
3.7. monitor and control and seized drug withdrawn from the chain stores and the liquidation;
3.8. collect checks for information on pharmaceutical regulatory compliance legislation, develop and submit proposals to the Ministry of health in the development of the laws and the improvement of the situation in the field of pharmacy.
4. inspections shall have the following rights: 4.1 external laws and cases, to request and receive, free of charge from the private inspection tasks required for the implementation of the information and documents;
4.2. According to competence to cooperate with national regulatory authorities, private individuals, as well as foreign institutions;
4.3. According to competence to organise seminars, conferences and congresses;
4.4. the administrative offences code, to examine the cases provided for in the administrative offences and impose administrative penalties;
4.5. free access to the drug shipment, storage, and distribution of medicines and medicine all documents lieltirgotav, pharmacies, medical institutions and social care institutions;
4.6. free access to the storage space of the medicinal products in customs warehouses and free customs zones;
4.7 in accordance with the laws and regulations in the field of pharmacy, prohibit or suspend the distribution of medicinal products;
4.8. to take a decision on the pharmaceutical company, pharmaceutical and pharmacy lieltirgotav suspension;
4.9. to give proposals on special permission (license) for pharmaceutical or veterinārfarmaceitisk operation of the cancellation or the pharmacist professional qualification certificate of cancellation;
4.10. to inform the public about the activities of the Inspectorate.
III. Inspection body 5. Inspection shall be led by the leader of the inspection. Inspection Manager performs the installation of Public Administration Act direct authorities managerial functions.
6. the head of the inspection shall be appointed and relieved of the post of Health Minister. The head of the inspection can be alternates.
7. the head of the inspection the inspection determines the organisational structure.
IV. Inspection activity ensuring the rule of law and reporting Inspection activities 8. the rule of law provide the head of the inspection. Inspection Manager is responsible for management decisions to the establishment and operation of the system.
9. the decisions of the officials of the Inspectorate and the actual action may be challenged, by submitting the application, the head of the inspection. The head of the Inspectorate's decision can be appealed in court.
10. the head of the inspection regulations issued (excluding this provision the decision referred to in paragraph 9) and actual action may be challenged in the Ministry of health. The Ministry of health decision may appeal to the Court.
11. inspection at least once a year, give the Health Minister's overview of the inspection function and inspection of the State budget allocated to the funds.
V. closing question 12. Be declared unenforceable in the Cabinet of Ministers of 6 august 2002, Regulation No 345 "national pharmaceutical inspection rules" (Latvian journal, 2002, 114 no; 2003, 180. no).
Prime Minister, Minister of finance Spurdziņš o. Health Minister g. Smith Editorial Note: regulations shall enter into force by 31 March 2006.