Key Benefits:
See the copyright notice Conditions of use .
In accordance with the decision of the Parliament:
The aim of this law is to prevent the illegal importation of narcotic drugs from Finland, from Finland to export, manufacturing, distribution and use of drugs and to reduce health risks associated with other substances used for the purpose of narcotic drugs.
This law applies to the control of psychoactive substances that are banned from the drugs and consumer markets. The law also applies to the control of drug precurnants, in addition to the control of precurnants in the Internal Trade and Outsourcing Regulation and the Implementing Regulation of the Deposits Regulations.
For the purposes of this law:
(1) Drug conventions; :
(a) the 1961 Single Convention on Narcotic Drugs of 30 March 1961 in New York (SopS 43/1965), as amended by the Protocol amending the 1961 Single Convention on Narcotic Drugs of 25 March 1972 in Geneva (SopS 42/1975) ( Single Convention of 1961 );
(b) the Convention on psychotropic substances of 21 February 1971 in Vienna (SopS 60/1976) ( 1971 Convention on Psychotropic Substances ); and
(c) Vienna, 20 December 1988, United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (SopS 44/1994) ( Convention on narcotic drugs and psychotropic substances, 1988 );
(2) By means of an internal market starting Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precurnants;
(3) By means of an external trade Council Regulation (EC) No 111/2005 laying down rules for the control of the trade in drug precurers between the Union and third countries;
(4) The implementing regulation of the starting materials regulations Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precurbation and Council Regulation (EC) No Commission Regulation (EC) No 1277/2005 laying down implementing rules for 111/2005;
(5) With a drug:
(a) substances and preparations belonging to the 1961 Single Convention on Narcotic Drugs;
(b) substances and preparations belonging to the 1971 Convention on Psychotropic Substances;
(c) substances whose control is decided in accordance with Council Decision 2005 /387/JHA concerning the exchange of information, risk assessment and control of new psychoactive substances;
(d) roofs ( Catha edulis ), cactus plants containing mescaline and Psilosyb mushroom; and
(e) substances used for drug-related purposes which are dangerous to health and which have been notified for control purposes in accordance with the Council Decision referred to in point (c), or which are located in the presence of such substances; Or which are medicinal products with a pharmacological characteristics as a narcotic drug;
(6) Drug precurtant Classified substances as referred to in Article 2 (a) of the Internal Trade Act and Article 2 (a) of the External Trade Extracts Regulation;
(7) Preparation of the drug Production, with the exception of all methods in which drugs can be produced, as well as cleaning up and converting the drug into another drug; and
(8) Drug production, The separation of opium, coke leaves, cannabis or cannabis resin from plants from which they can be obtained.
More detailed provisions on what substances, preparations and plants are treated as drugs within the meaning of paragraph 1 (5) shall be laid down by a Council Regulation.
For the purposes of this law, a psychoactive substance prohibited by the use of a psychoactive substance prohibited by the use of a psychoactive substance which may be hazardous to health and which has been notified for the purposes of control (1) In accordance with the decision of the Council referred to in point (c) of paragraph (c), or which are the patchwork of such substances and which are neither medicinal products nor drugs. The decree of the Council of State lays down more precise provisions on which substances are to be considered as prohibited psychoactive substances on the consumer market.
The psychoactive characteristics and risk of the substance referred to in Article 3 (1) (5) (e) and (3) shall be assessed by the Agency in cooperation with the health and development centre and the police and customs authorities. With.
If the Centre for Safety and Development in the pharmaceutical sector considers that the psychoactive and dangerous nature of the substance requires the implementation of the prohibitions in Article 5, the Centre shall submit its assessment to the Ministry of Social Affairs and the Ministry of Health and The draft measure, which is based on the rest of the way in which the substance is present in Finland or is likely to occur in Finland, before deciding whether to take control of the substance in accordance with Article 3 (1) (5) (c) According to the decision.
If the substance referred to in Article 3 (1) (5) (e) or (3) is based on a chemical product register of the Agency, or otherwise it may be presumed to be an industrial use, or if it is a substance, a substance or An assessment and a draft measure shall be provided for the known manufacturers of the medicinal product or their representative bodies. A decree of the Council of State may provide for minor derogations from the prohibition of the treatment of a drug in industrial use, where the substance is justified by the use of an industrial activity.
In addition, drugs and drug precurants, which are medicinal products, also provide for (185/1987) And elsewhere in law.
Prevention of drug use and the maintenance of problem drug users are laid down in the law on the organisation of prevention (523/2015) And in drug custody laws (1999) .
Production, manufacture, import into Finnish territory, exports from the territory of Finland, transport, transit, distribution, trade, handling, possession and use is prohibited. The prohibition may be waived for medical, research and supervisory purposes and for the purposes of industrial use, as expressly provided for in this Act or elsewhere in law.
The manufacture, storage, marketing, marketing and disposal of a psychoactive substance banned from the consumer market shall be prohibited. Derogation may be waived for research purposes and for the purposes of industrial use, as expressly provided for in this Act or elsewhere in law.
The transport of a substance without storage through the territory of Finland to another country shall be permitted if the operator has the export authorisation decision from the competent authority of the country of dispatch and the import authorisation issued by the competent authority of the host country.
An export authorisation and an import authorisation shall be submitted to the customs authorities for the transit of the narcotic to the customs authorities and presented before the entry into the country of the narcotic tranche.
The cultivation of the Kat plant (Catha edulis), Psilosyb mushrooms and coca is prohibited.
Cactus plants containing opium poppy, hemp and mescaline for use as a narcotic or in the manufacture or production of narcotic drugs are prohibited.
Anyone who has taken possession of a narcotic without being entitled to possession is obliged to immediately hand it over to the police or to the Customs or Border Protection Authority.
The Agency for Safety and Development in the pharmaceutical sector may authorise the manufacture of narcotic drugs, imports from Finland, Finland for export and treatment. (16/10/2009)
The authorisation may be granted to a private trader, a legal person, or to a university or other technical service:
(1) for the production of medicinal products and for other medical purposes, where, under Article 17 (1) of the Pharmaceutical Law, the operator is authorised to import medicinal products from Finland;
(2) for the manufacture, import, export or treatment of substances, preparations and test systems for the detection of narcotic substances if they contain drugs;
(3) scientific research and research into medical purposes, quality control research and product development; or
(4) for industrial use of the substance referred to in Article 3 (1) (5) (e), where the industrial use of the substance is authorised under Article 3b.
(10,2011/322)The holder of an authorisation under this law, in the performance of his/her duties in the performance of his duties, and the executor of the orders entrusted to it by the authorising officer, shall be entitled to possession of the quantity of drugs authorised in the authorisation; and The necessary transport.
The authorisation in accordance with this law shall not exempt the holder of the authorisation from complying with the requirements of the law and the provisions relating thereto.
The authorisation shall not be granted to a higher quantity of narcotic drugs listed in List I and II of the 1961 Single Convention on Narcotic Drugs as indicated in accordance with that Convention to the International Narcotics Control Board For the purposes of this year.
More detailed provisions may be adopted by the Government Decree setting out the quotas referred to in paragraph 3 and the fulfilment of the obligations of the Agreement.
The authorisation referred to in Article 9 (1) shall be subject to the condition that:
(1) the applicant shall have the staff necessary for the quality and scope of the operation, sufficient number of persons referred to in Article 16 and appropriate facilities, equipment and equipment;
(2) a private trader, persons belonging to the administrative bodies of the applicant for authorisation, and the managing director, in an open company, of company men, company-holders responsible for the commandites company, and at the University and other research institutes in the management positions of the entity; For persons:
(a) are of age;
(b) are well known and reliable; and
(c) are not bankrupt and their operational capacity is not limited;
(3) the authorisation of the applicant is appropriate for the fulfilment of the obligations laid down in Articles 25, 26 and 30 and in order to ensure that the substances covered by the authorisation are not used as narcotic drugs or drug precursors.
The safety and development centre of the pharmaceutical sector may consider that the applicant complies with the conditions laid down in paragraph 1, without separate identification, if the applicant regularly applies for authorisation from the Agency for Safety and Development in the pharmaceutical sector § 12 to 15. And the Agency for Safety and Development in the pharmaceutical sector has, in the last year, identified the applicant's activity as complying with the conditions laid down in paragraph 1. (10,2011/322)
A medicinal product authorisation may be issued for a maximum period of one calendar year. Manufacturing authorisation is not required for the manufacture of medicinal products for medicinal products. A manufacturing authorisation shall not be authorised for a drug without medical use.
The university or any other technical service may, notwithstanding the provisions of paragraph 1, authorise the manufacture of a narcotic substance for use in a scientific study if the institution concerned has a valid treatment permit as referred to in Article 15. Notwithstanding Article 15 (1) (5) (e), the narcotic substance referred to in Article 3 (1) (e) may be granted without prejudice to the authorisation provided for in Article 15 for the authorisation of the industrial use of the substance. The authorisation shall not be granted for a longer period than the permit is valid. (10,2011/322)
The authorisation may be accompanied by conditions relating to the storage, storage, transport, monitoring and disposal of substances and, where appropriate, other relevant factors.
More detailed provisions may be laid down by the Government Decree on the details of the permit conditions.
An import authorisation for a drug shall be issued for a period not exceeding six months. The import authorisation shall be granted per delivery per consignment, with the exception of the authorisation for an industrial application referred to in Article 3 (1) (5) (e) or a substance used for the detection of the substance, or A test system containing the drug. (10,2011/322)
The import authorisation may be accompanied by conditions for the import, quantity, storage, storage, transport, monitoring and disposal of the drug.
In addition to each import authorisation decision, an import licence shall be issued to the applicant to apply for export authorisation from the competent authority of the country from which the drug is imported. The authorisation holder shall inform the customs authority of the arrival of the drug in the country and present the import licence. The customs authority shall make the necessary particulars to the certificate and, where appropriate, attach any other explanation relating to the customs duty.
The authorisation holder shall return the certificate to the medical security and development centre immediately after the import of the consignment to Finland, but no later than the expiry of the period of validity of the authorisation. (16/10/2009)
More detailed provisions may be made by the Government Decree on the details of the permit conditions referred to in paragraph 2 and on the details of the content of the import licence and on the labelling thereof.
An export authorisation for a drug shall be issued for a period not exceeding six months. The period of time shall not exceed the period of validity of the import authorisation issued by the country of destination in Finland. The export authorisation shall be granted per consignment, with the exception of the authorisation for an industrial application referred to in Article 3 (1) (5) (e), or a substance used for the detection of the substance, and Test system. (10,2011/322)
When applying for an export authorisation for a substance, the import licence or other equivalent certificate issued by the competent authority of the country of destination of exports from Finland shall be provided that the import of the consignment destined for export to that country is authorised.
The export guarantee may be accompanied by conditions for the export, quantity, storage, storage, transport, monitoring and disposal of the substance.
In addition to each export authorisation decision, the applicant shall be issued an export licence. The authorisation holder shall inform the customs authority of the exportation of the drug and present the export certificate. The customs authority shall make the necessary particulars to the certificate and, where appropriate, attach any other explanation relating to the customs duty.
The authorisation holder shall return the certificate to the pharmaceutical safety and development centre immediately after it has been exported from Finland, but no later than when the authorisation expires. (16/10/2009)
The Government Decree may provide more detailed provisions on the details of the permit conditions referred to in paragraph 3 and on the details of the content of the export licence and the labelling of the export licence.
The authorisation for a drug treatment shall be granted for a maximum period of three years for scientific research or for research into medical purposes, quality control research or product development. The processing permit for industrial use referred to in Article 3 (1) (5) (e) may be granted only if the industrial use of the substance is authorised under Article 3b. (10,2011/322)
The authorisation of a drug processing authorisation shall not be required for the treatment and possession of medicinal products classified as narcotic drugs, where this is carried out in the law on medical professionals, (559/1994) Or by law relating to the exercise of the veterinary profession (2006) , or in the case of medical purposes referred to in the regulation adopted pursuant thereto, or in the performance of the legal function of the official laboratory of the competent authority. (10,2011/322)
The treatment permit may include conditions for the type, quantity, purpose, storage, storage, transport, monitoring and disposal of the drug.
More detailed provisions may be laid down by the Government Decree on the details of the permit conditions.
Any establishment carrying out activities requiring authorisation under this law shall be the person responsible and the number of surrogates required by the authorisation holder. The responsible person and his deputies shall be of full age and suitable for the task. In addition, they shall have the necessary powers to perform the task and adequate professional skills acquired through training or experience.
The person responsible for the job of the responsible person and his replacement shall be the person who, during the last 10 years of drug or drug abuse or drug abuse, has been committed during the last 10 years, There appears to be no ability to carry out the task due to violations or omissions in the law. An unsuitable job is also a person who is bankrupt or whose viability is otherwise restricted.
The Agency shall, in addition to the holder of the authorisation, accept responsibility for ensuring compliance with the provisions of this law and the provisions of the permit conditions, alongside the holder of the authorisation.
When submitting an application for authorisation, the applicant for authorisation shall submit an application to the Medical and Development Centre for the approval of the person responsible and the latter. Authorisation shall not commence until the activity in question has been approved by the responsible person.
In the event of the resignation of the responsible person or of his or her replacement, or failing to perform his duties, he/she shall be replaced by a new person or replacement and shall apply for approval in seven days.
The Agency for Safety and Development in the pharmaceutical sector shall withdraw the approval of the responsible person or the replacement if requested by the authorisation holder.
A responsible person or a replacement may be withdrawn for a whole or a fixed period if the responsible person or his substitute:
(1) no longer fulfils the conditions laid down in Article 16;
(2) has been convicted by a judgment of a criminal nature which demonstrates that he is manifestly unfit for responsibility; or
(3) has acted wrongly as a responsible person or alternatively as a substitute.
In the cases referred to in paragraph 2, the Agency may, instead of withdrawal of authorisation, issue a warning to the person responsible or to his surrogate, if the withdrawal of the approval would be disproportionate to the circumstances.
The Agency for the Safety and Development of the Medicinal Products shall inform the holder of the authorisation or of the withdrawal of the approval of the person responsible, or of the authorisation holder, who shall be employed by the responsible person or deputy.
An application for authorisation under this law shall include information on:
(1) the name or business name of the applicant, the contact details, the company and the Community symbol;
(2) the suitability of the applicant to carry out the activities subject to the authorisation;
(3) for each establishment where the activity requiring authorisation is to be carried out;
(4) the substances covered by the authorisation and their intended use and quantity;
(5) persons belonging to the applicant's governing bodies and of the managing director, the open company and the companies responsible for the management of the partnership, and those in managerial positions at the University and other research institutes;
(6) the persons responsible for each establishment and their alternates, as well as their dependability, competence and experience in the treatment of substances subject to authorisation;
(7) for the methods of establishing each establishment to prevent substances being used as narcotic drugs or drug precurers; and
(8) other similar reports and measures necessary to achieve the objectives and control of this law.
The operator is not required to make an authorisation for the information referred to in paragraph 1 (2) and (3) and (5) to (7) if the operator:
(1) regularly apply for authorisations pursuant to Articles 12 to 15 from the Agency for the Safety and Development of Medicinal Products; and
(2) has submitted to the Agency for Safety and Development in the pharmaceutical sector the information in respect of which no changes have occurred, during the last six months in the context of the second application for authorisation, and the Agency for the Safety and Development of Medici has kept: An explanation as appropriate.
(16/10/2009)The authorisation holder shall inform the Centre for Security and Development in the pharmaceutical sector of any changes to the information provided in accordance with paragraph 1 after the authorisation has been granted, which will affect the conditions for the authorisation. (16/10/2009)
More detailed provisions may be made by the Government Decree on the content of the report to be annexed to the application for authorisation.
The authorisation holder may only release drugs to the other holder of the authorisation or to someone who otherwise has the right to acquire, hold or process the substances disposed of.
The donor of the donor must explain the purpose of the drug to be handed over to the donor, which shall be referred to in Article 9 (2).
The Agency shall withdraw the authorisation in accordance with this law if:
(1) is requested by the authorisation holder; or
2) the authorisation has been terminated.
The Centre for the Safety and Development of Medicinal Products may suspend or revoke an authorisation granted under this law if:
(1) there has been a substantial infringement of the obligations or prohibitions imposed by this law or by the law adopted pursuant to it or elsewhere by law;
(2) the authorisation holder has substantially infringed the conditions of authorisation;
(3) the conditions laid down in Articles 9 and 11 no longer exist;
(4) the authorisation holder does not have a responsible person within the meaning of Article 16, or a person or person belonging to the management body of the holder of the authorisation, and, in an open company, a company man, a company man responsible for the limited partnership or university or In another research establishment, the senior officer of the unit shall have been convicted by a judgment of a criminal offence which demonstrates that he is unfit for his/her duties; or
(5) Whereas information on the application of the authorisation has been substantially erroneous in relation to information relating to the control of drugs.
In the event of an urgent case, the Agency shall, in the circumstances referred to in paragraph 2, have a written warning before the withdrawal of the authorisation, and shall set a period for the authorisation holder concerned To correct or eliminate the deficiencies in operation.
The Agency may also issue a note or a written warning to the authorisation holder, if any deficiencies, infringements or omissions may be remedied or minor.
The requested authorisation shall be returned to the Agency for Safety and Development.
The import and export authorisation under this Act shall not be necessary for medicinal products containing drugs intended for use in the first aid, including those contained in international transport, aircraft, ambulances and humanitarian Storage facilities for vehicles used in assistance operations.
The medicinal products referred to in paragraph 1 shall be kept in a sealed medicine cabinet in a sealed medical kit. They shall be responsible for the ship's master and the aircraft, ambulance and humanitarian aid operations in charge of the medical storage facility.
The import and export authorisation under this law is not necessary for the substances used in List III of the 1961 Single Convention on Narcotic Drugs and the substances used in the detection of narcotic drugs, For preparations and test systems with limited drug use or in which the drug is difficult to distinguish, and which may involve only a low risk of abuse in relation to the broad medical use of the substance.
The import and export authorisation under this law is not required for composite products containing the substance listed in List I of the 1971 Convention on Psychotropic Substances other than psychotropic substances, or manufactured, Containing a substance referred to in Article 3 (1) (5) (5) (e), containing only a limited number of narcotic substances, or in which the substance is difficult to distinguish and which can be associated with the comprehensive medical use of the substance only There is a low risk of abuse. (10,2011/322)
The decree of the Council of State may provide for more detailed provisions on the subject of authorised substances, preparations and test systems.
The authorisation under this law shall not be required for the substance referred to in Article 3 (1) (5) (e), where justified by reason of any other substance or preparation and the risk of misuse due to the limited quantity of the substance, or because of: The substance is considered to be difficult to use or in an erotic form.
The University and the Scientific Research Institute shall be allowed to import and store psychoactive substances prohibited from the consumer market for their research activities, where the substance and operation have been made prior to import notification of the safety of the pharmaceutical sector; - To the Centre.
The trader shall be allowed to import and store psychoactive substances prohibited from the consumer market for a justified reason for its industrial activity, where the substance and operation have undergone prior import notification of the safety of the pharmaceutical sector; - To the Centre.
The import, storage, marketing, marketing and disposal of a psychoactive substance banned from the consumer market shall be permitted where justified by any other substance or preparation and the risk of misuse due to the limited quantity of the substance Or because the substance is in a form which is difficult to use or in isolation, shall be considered to be negligible.
The decree of the Council of State may provide more specific provisions for the notification referred to in this Article.
The provisions of this Act concerning imports into Finland of narcotic drugs and exports from Finland shall not apply to those listed in List II-IV of the 1971 Convention on Narcotic Drugs of 1961 or 1971 on psychotropic substances Or medicinal products containing the medicinal product referred to in Article 3 (1) (5) (e), which the passenger uses for his personal medication. In this case, the provisions of Article 19 of the Act on Medicinal Products shall be complied with.
The manufacturer, the Finnish importer, the Finnish exporter, and the person involved in the transport and storage shall ensure that the import and export documents, including the release of the substance or preparation, have the necessary identification.
The Government Decree may provide more specific information on the identity of the information referred to in paragraph 1.
Drugs must be stored or otherwise kept in a separate, locked place where the bystanders have been prevented.
The Government Decree may provide more specific provisions for the storage and storage of narcotic drugs referred to in paragraph 1 and for those medicinal products which are not required to be kept in accordance with the provisions laid down in paragraph 1.
The transport of drugs and the accompanying measures shall respect the necessary care and care, taking into account the transported substance, its quantity and mode of transport.
Those involved in the transport and storage of drugs must ensure that the supply of drugs and any other illegal use has been prevented.
The decree of the Council of State may provide for more detailed provisions concerning the transport of drugs and the related treatment referred to in paragraph 1.
Persons entitled to the treatment of drugs are obliged to provide for disposal all medicinal products classified as narcotic drugs and other drugs which are no longer authorised under this law.
Substances and preparations referred to in paragraph 1 shall be disposed of only in a hazardous waste treatment plant. In this case, the waste law (166/2011) And environmental protection law (177/2014) Provisions on the disposal of hazardous waste. (27.6.2011)
By way of derogation from paragraph 1, the provisions of the Waste Law and the Environmental Protection Act shall apply to the disposal of narcotic drugs referred to in Article 3 (1) (5) (e).
More detailed provisions on the disposal of substances and preparations referred to in paragraph 1 may be adopted by the Government Decree.
The authorisation-holder shall immediately inform the Centre for Security and Development:
(1) the suspension of the establishment and the change in the address of the place of establishment;
(2) the change in the management body of the person and the managing body of the managing body, of the company man and of a company man responsible for the management of the partnership, and of a change in the managerial positions of the entity in the university and other research facility;
(3) closing or suspending operations for a longer period of one month;
(4) that the responsible person referred to in Article 16 or the Deputy shall cease to carry out the task; and
(5) any changes which have materially affect the conditions for granting authorisation after the authorisation was granted.
The holder of an authorisation under this law and the operator referred to in Article 15 (2) shall keep records of their manufacture, export, support and processing of narcotic drugs. However, the obligation of professional secrecy does not apply to medicinal products for personal use as prescribed drugs. The accounting records shall be kept for at least six years from the end of the year in which it was drawn up. The Centre for the Safety and Development of Medicine shall be entitled to receive the drug accounting records referred to in this paragraph. The Food Safety Agency and the regional government agencies have the right to be able to see veterinary drug accounting. (22/122009/1568)
The eradication of drugs must be recorded in the records of the drugs. The disposal and accounting of medicinal products supplied by customers to the pharmacy shall be subject to compliance with the separate provisions.
The decree of the Council of State may provide for more detailed provisions concerning the accounting and drug accounting records provided for in this Article and its preservation.
Before the end of January, the authorisation holder shall submit to the Agency for Safety and Development in the pharmaceutical sector:
(1) an indication of the quantities of drugs manufactured, stored, stored and disposed of in the previous year, and of substances and preparations containing drugs, and the quantity and quantity used; The manufacture of medicinal products;
(2) an indication of the drugs destroyed during the previous year;
3) an estimate of the need for the following year.
In addition, the holder of the authorisation shall report to the pharmaceutical security and development centre on a quarterly basis, on a quarterly basis, on imports from Finland and the 1971 List of Psychotropic Substances exported from Finland and 1971. Substances listed in List I of the Convention.
More detailed provisions may be adopted by the Government Decree on the notification requirement within the meaning of this Article.
The Agency for Safety and Development in the pharmaceutical sector may, if necessary, lay down provisions on the details of reporting.
The pharmacy shall monitor the submission of the substances and preparations contained in List I, II and IV of the 1971 Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances, and the supply of pentazocine and buprenorphine. The pharmacy and keep a record of it.
The pharmacy must provide information on the monitoring of medicinal products classified as drugs in the pharmaceutical sector on a monthly basis. (16/10/2009)
The monitoring and accounting information referred to in paragraph 1 shall be kept secret.
The Government Decree may provide more specific provisions for the monitoring of medicinal products classified as narcotic drugs, the eradication of monitoring data and the obligation of pharmacies to provide follow-up information to the Agency for Safety and Development in the pharmaceutical sector. (16/10/2009)
The placing on the market in accordance with the terms of the internal market starting material Regulation and the export and export performance of the source regulation and related brokering activities shall be subject to the obligations of operators, as well as in those Regulations, and The Implementing Regulation of the starting materials regulations.
Anyone importing or storing psychoactive substances prohibited from the consumer market shall keep records of the substances used for its support and research or production activities and shall ensure that the documents contain sufficient information: The quantity of the substance and the name and address of the seller and purchaser may be identified. Records shall be kept for at least three years from the end of the calendar year in which the import or storage has taken place.
Anyone importing or storing psychoactive substances prohibited from the consumer market shall provide a summary of the quantities of imported and stored substances and the main information used in the Pharmacovigilance and Development Centre. Substances and research or production activities. The data shall be provided on a calendar year at the latest on 15 February of the following year.
The General Council Regulation may lay down more detailed provisions on the obligation to supply records and information as referred to in this Article.
The highest management and control of this law and of the provisions and regulations adopted under this law are part of the Ministry of Social Affairs and Health.
As a competent authority within the meaning of this law as a competent authority within the meaning of the terms of reference, notification and control of the internal trade and external trade, and in the context of the regulation implementing the starting materials regulations, the safety and security of the pharmaceutical sector Unless otherwise specified.
In addition, the Agency shall be responsible for:
1) maintain a database on psychoactive substances banned from drugs and consumer markets;
(2) to carry out the collection tasks under this Act in so far as they are not included in the tasks of the Institute for Health and Welfare in accordance with Article 35.
Veterinarians are also supervised by the Food Safety Agency and the regional administration offices.
The decree of the Council of State may provide more specific provisions for the tasks of the Agency for the Safety and Development of the Medicinal Products, provided for in paragraph 3.
The health and welfare institution shall be responsible for:
(1) collect, produce and obtain information for statistical purposes and research on drugs and measures to prevent these illegal use;
2) to act as a representative of Finland in the European Information Network on Drugs and Drug Addiction in the field of data collection on the scope of this law.
More detailed provisions may be laid down by the Government Decree on the collection of data in accordance with this Act.
The Agency shall be entitled to inspect premises where the psychoactive substance prohibited by the drug, the drug precursor or the consumer market is produced, by the prescribing authority of the Agency, Are prepared, stored, stored or otherwise processed. The right of access shall also apply to prior checking under the authorisation and supervision of the Agency for the authorisation and supervision of the medicinal product in the pharmaceutical sector.
The inspector referred to in paragraph 1 shall be allowed access to all premises of the establishment. The inspection referred to in this Article shall not be carried out in the premises used for permanent housing.
The Agency shall have the right to receive assistance from the police, both customs and border guards, in order to carry out the task assigned to it under this Act.
In addition to what is in the administrative law (2003) , the inspection shall include all documents and other material requested by the inspector referred to in Article 36 (1) for the purpose of carrying out the inspection. The inspector shall be given, free of charge and without prejudice to the confidentiality rules, copies of the documents necessary for the inspection.
In the context of the audit, the inspector shall have the right to take samples of the drugs and preparations in the office separately for further examination. In addition, the inspector shall have the right to take the image storage media necessary for carrying out the inspection during the inspection.
The Centre for the Safety and Development of the Pharmaceutical Centre shall, notwithstanding the confidentiality of the information provided, have the right to obtain, free of charge, the information necessary for the purpose of carrying out the authorisation and surveillance tasks under this law, in accordance with the provisions of this Law and of the Medicinal Products From traders and other operators, as well as from the State and municipal authorities.
Without prejudice to the confidentiality of the information, the Agency shall be entitled to receive from the operators referred to in the Internal Market and Outsourcing Regulation and from the operators referred to in the , information which is necessary to monitor compliance with those Regulations.
Without prejudice to the confidentiality of information, the Agency shall have the right to obtain the information necessary for the performance of its duties under this law from the customs authority on foreign trade registers. Imports of narcotic drugs and drug precurts from Finland and Finland. Such information shall not be authorised without the authorisation of the customs authorities for purposes other than the purpose for which they have been surrendered.
The Centre for the Safety and Development of the Pharmaceuticals shall be entitled to obtain the supervision referred to in this Act and to grant the authorisation necessary for the granting of authorisations within the meaning of this Act and of Community legislation on drug precurbation Information on the enforcement of the fine (672/2002) Article 46 Of a financial penalty.
The right to obtain information from the criminal record is punishable by a criminal record (770/1993) .
Without prejudice to the confidentiality of information, the Agency shall, on its own initiative, hand over to the police, customs and border guards, and to the Office for Social and Health Authorisation and Control, the , which are necessary for the performance of the statutory tasks of the authorities.
The police, the customs authority, the border guard and other drugs involved in the fight against illegal use, the Ministry of Foreign Affairs and the Ministry of Justice and the Ministry of Justice and the Ministry of Justice must provide To the Security and Development Centre and to the Institute for Health and Welfare, the information necessary for the transmission of information to international supervisory authorities and data collection entities, unless otherwise covered by the obligation of professional secrecy Is.
In addition to the Pharmaceutical Safety and Development Centre, the competent authorities shall also be the police in matters relating to the prevention of psychoactive substances banned from the drugs and consumer markets, as well as customs and border guards On the prevention, import, export and transit of psychoactive substances banned from the market in narcotic drugs and consumer markets, as well as those authorities, as provided for in Article 8 of the Internal Market , Article 8 (1) of Regulation (ec) , Articles 9 (1), 14 and 26 and Articles 12 (2), 13, 16 and 23 (2) of the implementing Regulation.
An official who is entitled to arrest shall confiscate a narcotic which has been handed over to the police or to a customs or border guard on the basis of Article 8 or whose possession does not otherwise have the right under this law, but possession of which Is not punishable. The implementation of the guarantee shall be carried out in accordance with the provisions of (806/2011) in Chapter 7, Article 12 Provides for the Protocol and Article 14 to withdraw the seizure.
An official who is entitled to arrest shall be certified to dispose of or dispose of a narcotic and psychoactive substance prohibited by a confiscation or confiscation order. The provisions of Articles 28 and 30 shall comply with the provisions of Articles 28 and 30. However, the substance or part of the substance to be disposed of must be kept for as long as it is necessary to prove it in the trial.
A civil servant entitled to arrest may be certified to dispose of or dispose of a raw material, other substance, equipment or article intended for the illicit production, cultivation, manufacture, possession or use of a narcotic, May be seized if it is likely that it would be subject to confiscation of the State.
By a written decision of the Head of the Central Criminal Police or the Head of the Anti-Fraud Office, the authority responsible for the prevention, detection and investigation of drug offences in an individual case may authorise the importation of the drug Finland, exports from Finland or transit. (10,2011/322)
By a written decision of the master referred to in paragraph 1, the substances, equipment and articles referred to in Article 44 (2), seized or confiscated, may be transferred to the Authority for use by: The prevention, detection and detection of drug offences and the granting of a drug possession charge to the Authority for this purpose.
The decisions referred to in this Article shall be immediately notified to the Agency for Safety and Development. (16/10/2009)
The Centre for the Safety and Development of Medicinal Products may prohibit any infringement of this law or of the provisions of the internal market starting materials regulation or the external trade starting materials regulation, from continuing or repeating the unlawful conduct. The Agency for the Safety and Development of the Medicinal Products may also impose any other obligations on the Member States in breach of those provisions.
The Centre for the Safety and Development of Medicinal Products may intensify the prohibition or provision issued under this law by periodic penalty payments or at the risk of not having the measures taken at the expense of the defaulter or at the risk of being suspended. The withdrawal of the authorisation is provided for in Article 21.
The periodic penalty payment imposed shall be condemned by the Regional Administrative Agency, at the request of the Agency for Safety and Development in the pharmaceutical sector. The penalty payment, the threat to be made and the threat of suspension are otherwise provided for in the (1113/1990) . (22/122009/1568)
However, a periodic penalty payment shall not be imposed on a natural person as an element of the reporting obligation laid down in this Act where the person is suspected of having committed a criminal offence and the information relates to the subject matter of the suspected criminal offence.
Every intention or carelessness
(1) fails to apply for the authorisation provided for in Article 3 (2) of the Internal Trade Act or Article 6 (1) of the Expedition Regulation,
(2) fails to comply with the obligation to notify pursuant to Articles 6, 23b, 29 or 31 of this Act, the reporting obligation under Article 30 or Article 33a, or Article 32 (1) or Article 8 of the Internal Trade Act; or The reporting obligation provided for in Article 9 of the External Trade Exemption Regulation, (19/04/2013)
(3) in breach of Article 20 of this Act, or in breach of Article 25, the storage and storage of Article 26, the retention of Article 27, or the obligation to dispose of § 28 of Article 28;
(4) issue false information in Articles 12 to 16 and 19 of this Act, in Article 3 (1) and (6) of the Internal Trade Act, or in Article 7 (1), Article 13 (1) or Article 21 (1) of the Exporter Regulation; - or In the area of registration or substantially neglecting the necessary information,
(5) substantially infringes the conditions or restrictions attached to the authorisation referred to in Articles 12 to 15;
(6) fails to comply with the obligation laid down in Article 3 (6) of the Internal Trade Act or Article 7 (1) of the Exemption Regulation;
(7) does not comply with the provisions of Article 5 of the Internal Trade Departure Regulation or Articles 3 and 4 of the Exporting Extraction Regulation,
(8) does not comply with the provisions of Article 7 of the Internal Trade Extracting Products Regulation or Article 5 of the Exporting Extracting Products Regulation, or
(9) does not comply with the provisions of Article 5 of the Internal Trade Extraction Regulation on the customer's report;
Shall be condemned, unless the law provides for a heavier penalty in the rest of the law, On the drug law offences Fine.
Any violation of a penalty imposed by this law by a periodic penalty payment may be waived for the same offence.
Criminal offences are punishable under criminal law (39/1889) . Infringement of the ban on the prohibition of psychoactive substances prohibited in the consumer market Article 44 (5a) of the Penal Code .
The decision taken pursuant to Articles 18, 21 and 46 of this Act shall be subject to appeal by the administrative court in accordance with the administrative law (18/06/1996) Provides.
The decision to be adopted by the Agency for the Safety and Development of Medicinal Products for the purposes of this Act, the Internal Trade Act and the External Trade Act shall require an adjustment as provided for in the Administrative Law. The decision on the request for adjustment shall be subject to appeal by the administrative court as provided for in the administrative law.
In the case referred to in paragraph 1, the administrative right shall be subject to appeal as laid down by the Law on Administrative Law. An appeal against any other decision of the administrative court may be lodged only if the Supreme Administrative Court grants an appeal.
The decision of the Agency for the Safety and Development of Medicinal Products shall, in spite of the appeal, be complied with, unless otherwise specified by the appeal authority.
L to 1027/2015 Article 49 enters into force on 1 January 2016. The previous wording reads:
The decision to conclude this law by the Agency for the Safety and Development of Medicinal Products under this Act, the Internal Trade Act and the External Trade Act and the External Trade Act is amended as follows: (18/06/1996) Provides.
The decision of the Agency for the Safety and Development of Medicinal Products shall, in spite of an appeal, be complied with, unless the Authority decides otherwise.
This Act, hereinafter: New law Shall enter into force on 1 September 2008.
This law repeals the drug law adopted on 17 December 1993. (1289/1993) (hereinafter ' the Old law , with subsequent amendments.
Before the entry into force of this Act, measures may be taken to implement the law.
Where the law refers to the old law or its provisions, the reference shall be understood to mean a new law or equivalent provisions.
An authorisation granted under the old law shall be deemed to have been granted under the new law and shall cease to be valid on the date specified in the authorisation decision.
At the time of the entry into force of the new law, the pending case under the old law will be handled and settled in accordance with the provisions of the old law.
The authorisation holder shall assign to each of the sites covered by this authorisation, the responsible person referred to in Article 16 and shall notify this medicinal product for approval within six months of the entry into force of this Act.
In accordance with Council Decision 2005 /387/JHA concerning the exchange of information, risk assessment and control of new psychoactive substances, substances to be taken under surveillance shall be treated as new synthetic substances which have been repealed by that Council Decision Substances decided for control in accordance with Council Decisions 97 /396/JHA adopted under Joint Action 97 /396/JOS. Those substances may, if necessary, be subject to more detailed provisions by a Decree of the Government, equivalent to those referred to in Article 3 (1) (5) (c).
THEY 22/2008 , StVM 5/2008, EV 34/2008This Act shall enter into force on 1 November 2009.
Before the law enters into force, measures may be taken to implement the law.
THEY 166/2009 , StVM 28/2009, EV 122/2009
This Act shall enter into force on 1 January 2010.
Before the entry into force of this Act, measures may be taken to implement the law.
THEY 161/2009 , HVM 18/2009, EV 205/2009
This Act shall enter into force on 28 June 2010.
THEY 93/2010 , StVM 16/2010, EV 114/2010
This Act shall enter into force on 1 June 2011.
The methylene dioxide pyrovalvalerone referred to in Article 3 (1) (5), point (d), in force at the time of entry into force of this Act shall be regarded as a narcotic within the meaning of Article 3 (1) (5) (e) of this Law.
Before the law enters into force, action can be taken to enforce the law.
THEY 303/2010 , StVM 48/2010, EV 282/2010
This Act shall enter into force on 1 May 2012.
THEY 199/2010 , YmVM 23/2010, PeVL 58/2010, HVL 35/2010, TaVL 30/2010, EV 360/2010
This Act shall enter into force on 1 January 2014.
THEY 222/2010 , LaVM 44/2010 EV 374/2010
This Act shall enter into force on 1 September 2014.
THEY 214/2013 , YmVM 3/2014, EV 67/2014
This Act shall enter into force on 20 December 2014.
However, the provisions of Article 33a concerning the import and storage obligations of a psychoactive substance banned from the consumer market shall not apply until 1 April 2015.
THEY 327/2014 , StVM 34/2014, EV 243/2014, notified in accordance with Directive 98 /34/EC of the European Parliament and of the Council as amended by Directive 98 /48/EC.
This Act shall enter into force on 1 December 2015.
THEY 339/2014 , StVM 53/2014, EV 365/2014
This Act shall enter into force on 1 January 2016.
In the case of appeals before the entry into force of this Act, the provisions in force at the time of entry into force of this Act shall apply.
THEY 230/2014 , LaVM 26/2014, EV 319/2014
