The Ministry Of Social Affairs And Health Decree On The Imposition Of The Medicinal Product

Original Language Title: Sosiaali- ja terveysministeriön asetus lääkkeen määräämisestä

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In accordance with the decision of the Ministry of Social Affairs and health provides health professionals (559/1994), the third paragraph of article 22, article 23, section 2, subsection 2, paragraph 23 (b) and (d) of the first subparagraph of article 23, the medicine Act (395/1987) 57 (b) of article 5 of the law on the status and rights of the patient (785/1992) under article 12, as are health care professionals who act under section 23 (b) Article and article 23 (d) of the law, medicine Law 57 433/2010 section of the article 5 of the law on the status of the patient and the 80/2003 and article 12 of the law on the rights of the 2 law of 653/2000: Chapter 1 General provisions article 1 Scope this regulation lays down the criteria to be taken into account when prescribing medications, as well as the content and format of the prescription.
The imposition of veterinary medicinal products.


section 2 Definitions for the purposes of this Regulation: 1) medicinal product preparation or substance, the purpose of which is internally or externally when it is used to cure, relieve or prevent a disease or its symptoms in humans; as a medicinal product shall also be considered as a human health condition or a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions internally or externally, or substance;
2) proprietary medicinal product shall mean a medicinal product which has been manufactured or imported in accordance with the medicines Act (395/1987) for use as a medicinal product in accordance with the intended and which is sold or otherwise at the time of release for consumption in the sales package;
3) recipe for a medicinal product, which may not be delivered to the pharmacy prescription;
4) itsehoitolääkkeellä medicine, that may not be delivered to the pharmacy without a prescription;
5) pkv-medicinal product mainly in the central nervous system of the active ingredient of the medicinal product (a)) which is listed as a Centre for the development of the pharmaceutical industry on the list laid down by the security and pkv-medicines, (b)) that contains the main active ingredients are listed in the security and of the Centre for the development of the pharmaceutical sector in the list of those to be laid down by the pharmaceutical substances, which may be exchanged only on medical prescription only and that is to do so, you will find in this list a Z, ZA, P and PA, or (c)) that is specified in the marketing authorisation as a medicinal product pkv-;
6) with alcohol the product more than 5.0% ethanol containing a medicine;
7)-medicine pharmacy order self-help or prescription medication;
drug substance drug law 8) (373/2008) on drugs, referred to;
9) the actual drug substance to the 1961 Single Convention on narcotic drugs, as well as the lists of (I), (II) and (IV) the 1971 Convention on psychotropic substances with respect to substances containing (I) and (II) the lists of medicinal products;
the imposition of the written prescription of a medicinal product 10) a legitimate paper drawn up by the provision, on the basis of which the pharmacy to supply the patient with the drug;
the imposition of a medicinal product in the electronic prescription-11) of the person entitled to tietojenkäsittelylaitteella by prescription, which is transferred to the computer networks using the recipe and that is subject to the law on e-commerce prescription (61/2007);
12) to be kept in for prescription prescription that the patient medication delivery is left to the pharmacist;
13) drug prescription from a doctor or a dentist's prescription drugs set out on the form, the drug at the pharmacy for the prescription to be retained within the meaning of the provision;
14) alcohol prescription issued by a medical practitioner or dental practitioner, exclusively for ethanol (96%) or the supply of denatured ethanol in a pharmacy meaning, to put it mildly;
15) fax a prescription to your doctor or dentist to the pharmacy by the telecommunications organization concentrates on medical prescription;
16) telephone prescription issued by a medical practitioner or dental practitioner by telephone to the pharmacist a prescription;
17) pro auctore-prescription prescription, in which the doctor, dentist, optician or a dental hygienist in the exercise of their profession with the necessary amount of medication;
18) medicine order corresponding to a doctor or dentist for the supply of the medicinal product, for the hospital's express written provision in the health centre, private health-care services, the activities of the producer of the unit or the unit of social welfare policy; similar to the doctor and the dentist will have the right to pursue the profession independently licensed professional; drug order is also in the hospital pharmacy or medicine, signed by order of the installation concerned and details of the Centre's Manager or the medicine Act (395/1987) of the uses referred to in article 62, as well as the representative of the shipowner or master of the ship the order signed by the ship down to the Pharmacy;
19) the renewal of a prescription drug's prescriber (repetitio) are outside the United States by order of the entry of the pharmacist for a medicine or telephone notification, on the basis of which a pharmacy may submit the prescription medicines;
20) iteroidulla prescription the prescription of a medicinal product on the basis of the prescriber's label, which can be delivered periodically.
the exchange the exchange the medicinal product provided for 21) pharmacy medication dispensing medicine in accordance with section 57 of the laws of the (b); (20.12.2013/1129) 22) vaihtokelpoisilla medicine in preparation of pharmaceutical products, which are similar in terms of the active substances and their quantities, which are biologically equivalent and who are included in the security and of the Centre for the development of the pharmaceutical sector to confirm the list with each other vaihtokelpoisista on pharmaceutical products; as well as the (20.12.2013/1129) in the imposition of a European prescription medicinal products of 23) of the person entitled to in writing or by electronic means in the European Union or the European economic area or Switzerland in the second by the prescription on the basis of which the European Union or in the European economic area, a pharmacy may submit the medicinal product to the patient. (20.12.2013/1129), Chapter 2, section 3, the right to prescribe medication a doctor to prescribe drugs from the medical profession to independently engage a qualified person shall have the right to prescribe drugs to humans for the purpose of medical or medical pro auctore-prescription profession.
Primary care doctor has the right to impose additional training, running drugs, in accordance with paragraph 1. He did not, however, have the right to obtain drugs pro auctore-prescription.
Temporary medical task-based pharmaceutical science students have the right to prescribe drugs only in the task hoitamilleen patients.


section 4 of the dentist's right to prescribe medications to the dental profession independently to a qualified person shall have the right to prescribe drugs to humans for the purpose of hammaslääkinnällistä or hammaslääketieteellistä pro auctore-prescription profession.
Continuing the practice of the service running a dentist has the right to prescribe drugs, in accordance with paragraph 1. He did not, however, have the right to obtain drugs pro auctore-prescription.
Temporary dental mission senior dental students have the right to prescribe drugs only in the task hoitamilleen patients.
A dentist has the right to impose the full drug pharmaceutical products at the same time as read at once for a maximum of 10 distribution unit. Other than the dental specialist may provide no more than the smallest pkv-medicine myyntiluvallisen.


section 5: limited to prescribing nurse and as a nurse licensed nurse and midwife who has received health care professionals who act in accordance with section 23 (b), the written order is entitled to prescribe medicines in a pharmacy in accordance with a written order received to be delivered. The prescription of a medicinal product within the restricted drugs, disease and drug prescription limit orders is set out in annex 1. Written prescription formula is attached to 4. In General, the extension of the crop or medication medication is associated with the child's age.
Nurse, public health nurse and the midwife prescribe medicine for the strength of the active substance, and on the basis of the pharmaceutical form.


section 6 of an optometrist to prescribe medications for the optician may provide pro auctore-prescription pharmacy medicinal products referred to in annex 2 to the receiving of the information it needs.
Optometrist does not have the right to prescribe drugs to patients.


section 7 of the dental hygienist to prescribe drugs from a dental hygienist may provide pro auctore-prescription pharmacy medicinal products referred to in annex 3 to its activities, the information it needs to the front desk.
Suuhygienistillä does not have the right to prescribe drugs to patients.
Chapter 3 section 8 of the closing of the prescription, in agreement with the patient's Medical treatment


Medicinal treatment must decide, in agreement with the patient. Drug prescriber must provide the patient with sufficient information on the purpose and use of the medicinal product.


section 9 of the Drug määrääjien and pharmacies in cooperation, where appropriate, in cooperation with the prescriber of the medicinal product will be used by his patients in general medical medicine pharmaceutical Pharmacy staff with advice, as well as a safe, effective and economical drug therapy.


section 10 of the prescribing the drug määrääjä may prescribe drugs only to the person whose need for the medication he has taken on its own through their research, or otherwise in a reliable manner. The need for the medication, as well as to the efficacy of the medicinal product, select Security and will pay special attention to.
Drugs may have to comply with the marketing authorisation and the competent authority otherwise limitations. A prescription must also take into account the possible use of the recommendations.
The renewal of the call for the provision of a medical prescription, and that the määrääjä has personally examined the patient during the preceding year. Personal research is not, however, be required if the doctor or the dentist to a patient on the basis of the documents or other information to reliably ascertain the need for medical care. Nurse, public health nurse or a midwife must not allow and new prescription only on the basis of a medicinal product of any discrepancy found necessary for the receipt.
Medicinal products must provide the sizes of trade in equivalent quantities. If there is a specific therapeutic criteria can be different from the standard presentation of the medicinal product prescribed. Long term treatment for medication will be to try to start with a small package, and the drug is proving to be to fit the size of the economic package to control the drug. You can limit the period of validity of the medical prescription of a separate "per usum ad".


Article 11 of the abuse of the abuse of the prescription of a medicinal product suitable for the appropriate determination of the medicinal product shall comply with the special care and caution.
Drug prescriber should be monitored, if possible, in order to prevent the development of dependence on actual use of the medicinal product. Lääkeriippuvuutta suffering from the patient's treatment should be, as far as possible, to focus on one to the doctor.
The patient must not be imposed on the first-the abuse of appropriate drugs, unless the medicinal product visit määrääjä see the medication is necessary. Ensiapuluonteiset prescriptions should be limited to small in order to prevent abuse.


Article 12 of the Written Prescription Drug order for the drafting of the social insurance institution should be used for this purpose in accordance with a formula to be determined by the forms, unless a reasonable cause.
A prescription must be written by hand in clear handwriting, typed or automatic data-processing system. A prescription must contain only those entries, and bug fixes that may not lead to false interpretations. The drug provision of the corrections shall establish an autographed, name clarification and the date. If the provision of a medical prescription for the reserved items are full, it may not be new, but in this case, will be to draw up a new prescription.
The imposition of a medicinal product must not be used in the form in which the name of the medicinal product is already printed or stamped. Prescription forms should not be signed or stamped in advance. Forms and stamps should be stored in such a way that they may be unauthorized.


section 13 of the Drug provision of the relevant information (20.12.2013/1129), the provision of medicinal products shall be labelled: 1) the patient's name, date of birth or personal identification number, and the weight of less than 12 years old;
2) name of the substance or of the active drug or pharmaceutical product trade name, pharmaceutical form, strength of the medicinal product or the duration of the treatment in figures or letters or both, the ban on the exchange of medical, a composition of the medicinal product to be manufactured, as well as a pharmacy and label;
3) dosage of the medicinal product, the use of the medicinal product, and the medication type, i.e., whether the medicinal product is to be used, if necessary, or on a regular basis, as well as the intended use of the medicinal product and, if the exclusion is not reasonable cause; the accounting policies of the prescription, as well as 4) city and date, drug identification and the prescriber as well as the handwritten signature, and, where appropriate, the degree of specialisation.
(20.12.2013/1129)
If your doctor or dentist to use the name of the stamp, instead of, as provided for in paragraph 4 it shall be sufficient that the identification, as well as information on the educational value and engineering, emerge from the name leimasimesta. (20.12.2013/1129)
In addition to what is provided for in paragraph 1 and 2, the European medicine is an important drug prescriber as well as direct contacts and business address. In addition, the medicine will provide the name of the active drug substance. If you order the product is a biological medicinal product is to be used for medicinal prescription, however, the trade name. Prescription can be used in the name of the medicinal product, if the drug trade is also issuing a health-care professional deems it necessary for medical reasons. In this case, the prescription shall be presented briefly the reasons for the use of the trade name. (20.12.2013/1129)
Medical and dental students should mark the official order of the AIF it manages, the medicinal products or made and the work place. As a nurse, public health nurse, and midwife will mark the official order of the AIF it manages, the medicinal products or made and the work place.
A prescription will be labelled a "Sic", if the donor exceeds the approved summary of the product characteristics of the prescription dosage help or if the notified body ex tempore-dose exceeds the myyntiluvallisen corresponding to the composition of the medicinal dosage in the rest of the known source of help or enimmäisannostuksen.
Prescribing a prescription set out in only one drug is pulled to the other place reserved for box of the form over the line.


section 14 of the Fax-Prescription Drug määrääjä may offer to send the social insurance institution of Finland medical prescription form in accordance with section 12 and 13 of its prescription to the pharmacy tv in a fax. Fax a prescription to use will be limited only to specific situations. Telefax-prescription may be new and again for delivery.
Telefax-prescription not provide prescription medicines to be retained. The Organization concentrates on television may provide no more than the size of the smallest packing pkv-medicine.
Nurse, public health nurse and the midwife must not provide fax-prescription.


section 15 Phone Prescription Drug määrääjä may give a prescription to the pharmacist, if the medicinal product personally on telephone reporting the use of telephone prescription there is a justified reason. When a prescription is taken into account in the examination of the patient and of the medicinal product, what. Phone prescription must contain the same information as the written prescription.
The phone is not allowed to impose the provisions of prescription medicine to be retained. The phone may provide no more than the size of the smallest packing pkv-medicine.
Nurse, public health nurse and the midwife must not give the phone a doctor's prescription.


section 16 (26.3.2015/347), the period of validity of the Prescription Drug order shall be valid for a period of two years from the date of its disposal or renewal. Pkv-drug prescriptions, drugs, drug prescriptions and pro auctore-prescriptions, however, are only valid for one year from the date of its disposal or renewal.
The limitation of the period of validity of the medical prescription provided for in section 10 (4).

A 347/15 entry into force of the amended section 16 of the 1.1.2017. The previous wording: the period of validity of section 16 of the Prescription Drug order shall be valid for one year from the date of its disposal or renewal, if the period of validity of the order määrääjä of the medicinal product have not been restricted to 10 within the meaning of article.


section 17 of the medicine Exchange Drug prescriber will tell the patient that can be exchanged for convertible for the proprietary medicinal products at the pharmacy to the corresponding lower product. If the drug määrääjä the reasons for the ban to be told of the Exchange, it is prohibited for the patient.
If the drug määrääjä to prohibit the exchange of the medicinal product, shall be entered in the order of prohibition for medicinal and medical instructions. Exchange shall be prohibited "is not the medicine exchanges". The ban should not be given the medicine. The ban will not be used for stamps and lääkkeenmääräämisohjelmisto will automatically add and to the provisions of the proposed ban on the drug. If the drug määrääjä wants to impose on the holder of the marketing authorisation for a particular proprietary medicinal product, the name of the medicinal product, the order of the mark, the name of the holder of the marketing authorisation and a ban on entry.


the provision of article 18 of the prescription again


You can limit the supply of the medicinal product, the medicinal product määrääjä to happen periodically, iteroinnilla or by ordering a prescription for delivery again. For the provision of medicinal products shall be entered in the "iteration of the iter semel" (once again), "iter bis" (twice), or "iter ter" (three times).
Iteroituun medicine provision may be marked with the date of delivery by early again supply minimum number of days, weeks, or months in the previous delivery. Iteroitua a prescription shall not be again, after more than one year has elapsed since the adoption of the provision.
The following prescriptions may be imposed for delivery: 1) been delivered or renewed prescription;
2) retain the prescription;
3) pro auctore-medical prescription;
4) telephone medical prescription;
5) European.
(20.12.2013/1129), section 19 of the renewal of a Prescription Drug määrääjä a set form, may be renewed for a maximum of three times delivered a prescription, subject to renewal, not banned as "the rep". The name and quantity of the preparation should be renewable renewal entries in the space provided. The renewal of the entries must be included in section 13, subsection 1 (4) and (2) of the data.
In accordance with article 17 of the medical order marked the ban for the Exchange does not apply to the newly redesigned prescription medicines. If the drug määrääjä wants to ban the medicine sales for the newly redesigned prescription on delivery, comes this note in the box reserved for the entry by the renewal of the State of "no medicine exchanges".
If the amount of the medicinal product, or its dosage is changed, will this mark, as well as prescription renewal form on the home page to the appropriate section. Changes the name of the clarification shall be certified by an autographed, and date. If the renewal entries can lead to confusion, rather than come up with a new prescription will be renewed.
The following prescriptions cannot be renewed: 1) iteroitu prescription;
2) retain the prescription;
3) telephone medical prescription;
4) European.
(20.12.2013/1129)
Nurse, public health nurse and the midwife can not renew a prescription over the phone.


section 20 of the determination of the actual drug Drug määrääjä may provide to the patient or pro auctore-prescription drug prescribed for actual drug only prescription form or by means of an electronic prescription to the patient. The actual drug not be prescribed by order of the European medicine. (20.12.2013/1129)
The list of the 1961 Single Convention on Narcotic Drugs and psychotropic substances to the list of Convention IV (I) of the drugs not be prescribed.
Notwithstanding the provisions of paragraph 2, the drug määrääjä may order to the list of the 1961 Single Convention on Narcotic Drugs erityislupavalmisteena also (IV) and the Convention on psychotropic substances of list I drugs, if there is a specific hoidolliset.
Työpisteittäin drug prescription forms must be kept locked up. Health and social care, a business entity, you must post the työpisteittäin prescription form number, the patient's name, personal identification number and the name of the giver of the prescription.


section 21 requiring the imposition of a medicinal product to be retained in the prescription Medicine can be prescribed only by a separate medical prescription to be kept, if the marketing authorisation of a medicinal product 1) is attached to the option säilytettävästä the prescription; or 2 the main active ingredients contained in the medicinal product) is mentioned in the Centre for the development of the pharmaceutical sector in accordance with a list of safety and of the drugs, which may be delivered only by prescription, and which is equipped with the prefix ZA or PA.
Keep a medical prescription shall be drawn up by the social insurance institution of Finland on a form to be determined by the formula corresponding to the recipe, and may not be new, in addition, impose on a tv or on the phone. At the same time, the form will not be prescribed other medicinal preparations. Will be retained in the prescription drug not be prescribed by order of the European medicine. (20.12.2013/1129)
Keep the medicine can be a patient but also an electronic prescription.


section 22 of the Alcohol and an alcoholic prescribing Doctor may provide for ethanol (96%) and, to put it mildly denatured ethanol to be kept in the pro auctore-prescription of their profession in the medical and medical purpose, subject to the following restrictions: 1) ethanol (96%) for each calendar year of not more than 4 000 ml; 500 ml prescription shall be a maximum of alkuperäispulloa ethanol (96%); will try to replace the slightly methylated ethanol 9 and 12;
2) at the same time to change the prescription medicine should not be imposed.
The dentist may prescribe alcohol for the exercise of their profession in hammaslääkinnälliseen and subject to the limits laid down in paragraph 1, non-medical.
The doctor has the right to impose a mildly denatured ethanol dilutions of the patient for external use.
The doctor has the right to impose alcohol-based medicines to patients. For internal use on the nature of the medicinal products may contain not more than 20% (m/m) of ethanol, if the mixture as the main active ingredient is something other than ethanol. If, in order to ensure the protection of the active substances to dissolve or necessary to use more than 20% by weight of ethanol, can be mentioned in the above to the extent it is necessary.


pursuant to article 23 of the law of the imposition of a Erityislupavalmisteen Medicine 21 (f) referred to in article erityislupavalmisteen requires that the patient's treatment is not available in the other treatment, or that such a Board does not reach the desired result.
Establish a special permit that requires that the medicine is in addition to the prescriber as well as draw up a prescription of a medicinal product a statement of the specific reasons why the sairaanhoidollisista erityislupavalmistetta is required. If erityislupavalmistetta is used only in the hospital, health centre or private health-care services, the activities of the producer unit, the patient does not need to be identified.
Chapter 4 miscellaneous provisions article 24 of the medical tasks entries and a separate accounting of Drug prescriber must record all the provisions of domestic law which they adopt, and uusimansa medicine patient documents in such a way that the entry occurs: 1) to the date of the prescription;
the trade name of the medicinal product or 2) the medicine with active ingredient or ingredients and strength;
3) package size;
4 delivery of) the possibility of again;
5) purpose of use and help; and the reason for the ban, if the medicinal product 6) määrääjä is a banned medicine.
Drug prescriber must keep separate accounts for the provisions, the provisions of the pharmaceutical drugs, alcohol and pro auctore-medicine. Shall be recorded in the accounts of the same information as the medicine. The patient entered in the accounts in respect of the provisions recorded in the medicine for the diagnosis, the treatment of the measures carried out and.
The patient must, on request, on the basis of the accounts, documents, and gives an explanation of the imposition of the medicinal product, in health care and social services to the Agency and the area for the authorisation and supervision of the Management Board of the Agency.


ensuring patient safety in section 25 of the business entity must be a method for monitoring of medication prescriptions on occurrence reporting and processing. Pitkäaikaissairautta in the treatment of a patient suffering from compliance with the rights of a patient's medical status and Act (785/1992) of the patient's treatment plan, indicating the treatment, including medical treatment, organization and timetable for implementation. (26.3.2015/347)

A 347/15 modified the Act shall enter into force on the 1.1.2017. The previous wording is: a business entity must be a method for monitoring of medication prescriptions on occurrence reporting and processing.
Sairaanhoitajalla, the nurse and the midwife must, as well as medical students must have the opportunity to consult independently operate legitimate doctors and dental students independently to act in matters relating to the medicinal product in the imposition of a legitimate dentists. If the patient needs medical treatment hoitajavastaanotolla, a registered nurse, public health nurse or midwife may prescribe or in the patient's care requires a doctor's assessment, it is for the patient to be organized within a reasonable time, access to a doctor.
As a nurse, public health nurse, and midwife, as well as medical and dental students must establish a written management plan to comply with the patient's medicine and health care policy unit of the national treatment based on a recommendation from the guidelines.


section 26 of the Electronic prescription Electronic prescription drawn up must comply with what the law and the regulation of the electronic prescription (485/2008), as well as in addition to the provisions of this Regulation shall apply mutatis mutandis.
E-medicine provision does not apply to the provisions of section 19 of this regulation.


Article 27 entry into force


This Regulation shall enter into force on 1 January 2011.
This regulation repeals the imposition of 6 August 2003, the drugs of the Ministry of Social Affairs and health regulation (Regulation (EC) No 726/2003).


Annexes 1-4: the change in the imposition of the medicinal product, the entry into force of the acts of the STMa and application: 20.12.2013/11: This Regulation shall enter into force on 1 January 2014.




26.3.2015/347: This Regulation shall enter into force on the 1 January 2017.