In accordance with the decision of the Council of State, which was the presentation of the Ministry of Social Affairs and health, laid down 30 May 2008 on the Narcotic Drugs Act (373/2008): the scope of application of article 1 this regulation lays down, for the Narcotic Drugs Act (373/2008) on the functioning of the Administration, in accordance with the entry permit and control.
section 2 of the Quotas each year, submit to the medical products agency is the International Narcotics Control Board for the purposes of establishing quotas for the following year, the medical and scientific reviews for research purposes relating to the 1961 Single Convention on Narcotic Drugs of the quantities of substances in lists I and II.
If the import authorisation would result in exceeding the quota, is the medicine of the institution shall be presented to the International Narcotics Control Board for the purposes of establishing the supplementary assessment of a new quota. Permission will not be granted until a new quota has been established.
section 3 of the import and export licences in the drug import and export certificate shall state the name of the drug substance, and possible international non-proprietary name of the drug, the quantity of the substance in question, or of the importer and the sender's name and address of the exporter and of the consignee, the period within which the import or export must be carried out, as well as the Narcotic Drugs Act section 13, subsection 2, and the third paragraph of article 14 of the conditions laid down under. The export certificate shall, moreover, indicate the number and date of the import authorisation as well as the authority, that is it.
If the drug is imported or exported after processing, the certificate shall, moreover, indicate the name of the preparation, if any, together with the pharmaceutical form.
In the context of the import and export of drugs, the customs authority is an important Medicine to an import or export licence or certificate for the shipment of a bill of lading or invoice number, customs officer's signature, name, date and stamp of the Customs Office of destination.
The holder of the authorization, in addition to a copy of the certificate shall be returned to the Medical facility of the Bill of lading or invoice.
section 4 of the Import conditions to be attached to the permit and the restoration of the import licences shall be accompanied by the documents, according to which the imported to Finland in a customs warehouse shall be prohibited. For specific reasons, the option can be left without the list of the Convention on psychotropic substances other than (I) the import of drugs, I promise, the promise is individually significant approval of imports in a customs warehouse.
When an import permit which requires the drug is imported or import the specified time has elapsed, the medicine shall be returned to the competent authority of the country of export, a copy of the export licence, which is marked with the date, as well as the import of data from an imported drug.
section 5 of the drug on the packaging, identification of the drug must show the name of the substance as it is indicated in the 1961 Single Convention on narcotic drugs or the Convention on psychotropic substances. In addition to the packaging of the drugs referred to in substance is offered for sale shall indicate the concentration of the drug substance or preparation on the market.
section 6 of storage and storage of drugs, the pharmaceutical factory and the wholesale distribution of medicinal products may not be in stock drug more than what is necessary for the normal use or for the purpose of sale, taking into account the prevailing market conditions.
The lists of the Convention on psychotropic substances (III) and (IV) preparations containing substances will be retained for the location to which unauthorised access is as effective as possible.
section 7 of the destruction of the drugs, the 1961 Single Convention on narcotic drugs list in (I), (II) and (IV), as well as of the Convention on psychotropic substances lists (I)-(III) the destruction of the substances and preparations shall be drawn up, which shall be entered the name, quantity and lot number of the drug. The minutes shall be signed by two persons, one of whom must be a responsible person. An entry shall be made for the destruction of the drug records and the accounts of the Protocol is attached.
section 8 of the pharmacies in the accounting of the Pharmacy shall keep a record of the 1961 Single Convention on narcotic drugs, as well as lists (I), (II) and (IV) the Convention on psychotropic substances lists (I)-(III) substances and preparations.
Drug records contain the following information: 1 the name of the drug or preparation;)
2 the number of acquired inventory, acquisition date) and the acquisition of the place;
3) issued, date and recipient or patient;
5 the name of the prescribing practitioner);
6) recipe journal or the production batch number; as well as the initials of the person who performed the 7) entries and date.
under section 9 of the Hospitals and health centers, hospital pharmacy and 1ääkekeskuksen records shall keep a record of the 1961 Single Convention on Narcotic Drugs and psychotropic substances in lists I-IV of the Convention on the list (I)-(III) substances and preparations. The drug accounts shall correspond to the information in the article I, section 8. The patient's and the doctor's name, rather than the General Ledger shall be entered in the Department or unit, to which the drug or preparation is delivered.
When a hospital pharmacy or medicine centre shall forward to the Department, or any other operating unit or a pharmacy shall provide a on the basis of the 1961 Single Convention on Narcotic Drugs of pharmaceutical order lists (I), (II) and (IV) or the Convention on psychotropic substances lists (I)-(III) a substance or preparation must be accompanied by the consumption of pakkauskohtainen card. The name of the card holder must be the consumption of the product, quantity, delivery date and the name of the Department or of the activities of an entity. Consumer card must be in the patient's name, taken from the name of the medicinal product used in the dose, the doctor's name and the date of preparation.
When the product is used up, the card has the label of a possible defeat for the measure to be returned instead of the preparation in the hospital pharmacy, Medical Center, or the Pharmacy Department, or signed by a doctor responsible for the operating unit.
section 10 of the Pharmaceutical wholesalers, and the pharmaceutical wholesale trade in Medicinal and pharmaceutical records factory shall keep a record of the single Convention on Narcotic Drugs of 1961 could include: (I) (IV) of the lists and the lists of the Convention on psychotropic substances (I)-(III) substances and preparations. Medicine factory is also to be considered by the Convention on psychotropic substances with respect to substances in the book IV of the list, which will be reflected in the amounts of drugs have been used. Medicine factory accounting obligation also applies to those preparations containing psychotropic substances, which are exempted from the permit requirements.
Pharmaceutical wholesalers and pharmaceutical drug records contain the following information: 1 the name of the drug or preparation;)
2 the number of and the acquisition) storage become;
3) issued and the place;
4) inventory; as well as changes to the entries in the name of the person who performed the 5) letters and date.
Medicine factory is in addition, keep a record of the quantities, as well as in the manufacturing process of which the loss.
section 11 of the public authorities and the treatment of licence holders accounting authorities, who have the right to keep a stock of drugs, as well as drug treatment of licence holders shall keep a record of the drug, as well as in the pharmaceutical wholesale trade provided for in article 10. However, instead of the place of dispatch shall be entered in the data.
The Protocol drawn up by the authority of the confiscated drugs shall be kept for the purposes of subparagraph (1) the following are.
Article 12 of the drug importers and maastaviejien accounting maastavievän importing drugs and shall keep a record of the 1961 Single Convention on Narcotic Drugs and psychotropic substances in lists I-IV of the Convention on the list (I)-(IV). The records shall also be they drug amounts included in those products, for which the importing or exporting is exempt from permit requirements.
Drug importers and maastaviejien in the records of the following information: 1 the name of the substance and the quantity of drugs;)
2) which countries export or from which countries imports have been made;
3) in the import and export of the date; as well as 4) an import or export authorisation number.
The books will be reflected in the quantity of drugs, as well as other customs entry customs entries with dates.
section 13 of the veterinary records of animal doctors must keep records of the 1961 Single Convention on Narcotic Drugs and psychotropic substances in lists I-IV of the Convention on the list (I)-(III) substances and preparations.
Veterinary drug records contain the following information: 1 the name of the drug or preparation;)
2) storage or issued and the date;
3) inventory; as well as 4) with a report on the supply of a drug is used in the or.
Article 14 entry into force This Regulation shall enter into force on 1 September 2008.