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In accordance with the Ministerial Decision of the Ministry of Social Affairs and Health, the Article 22 of the ec Treaty (3), Article 23 (2), Article 23b (3) and Article 23d (2), (395/1987) Of the Law on the Status and Rights of the patient (785/1992) (2), as referred to in Article 23b (3) and Article 23d (2) of the Law No 433/2010, Article 57 (5) of the Medicinal Law No 80/2003 and the Law on the status and rights of the patient § § 2 of Law 653/2000:
This Regulation lays down the criteria to be taken into account when prescribing medicinal products and the content and form of the prescriptions.
The prescribing of veterinary medicinal products is regulated separately.
For the purposes of this Regulation:
(1) Medicinal product A preparation or substance that is intended to improve, reduce or prevent the disease or its symptoms in humans, either internally or externally; it is also considered a medicinal product to determine the cause of the state of health or the disease; or The preparation, repair or modification of vital functions internally or externally or the substance;
(2) Medicinal product Of a medicinal product manufactured or imported under a medicinal product (185/1987) , intended for use as a medicinal product, which is sold or otherwise released for consumption on the packaging;
(3) Prescription medicine A medicinal product which must be supplied only with a prescription;
(4) Self-treatment medicine A medicinal product which may be supplied by a pharmacy without a prescription;
(5) PkV medicinal product Medicinal product mainly affecting the central nervous system
(a) is listed in a list of medicinal products to be established by the Pharmaceutical Safety and Development Centre;
(b) whose main active substances are listed in a list established by the Agency for the Safety and Development of Medicinal Products, which may be supplied with a prescription only and which are listed in that list; Prefix Z, ZA, P and PA; or
(c) is a medicinal product specified in the marketing authorisation;
(6) Alcohol-containing medicinal product More than 5,0 % by weight of a product containing ethanol;
(7) Ex tempore medicine Self-care or prescription-only medicines to be prepared in the pharmacy;
(8) Drug use Drug law, (3703/2008) Of narcotic drugs;
(9) With an actual drug Medicinal products containing substances included in lists I, II and IV of the Single Convention on Narcotic Drugs of 1961 and the 1971 Convention on Psychotropic Substances;
(10) With a written prescription A prescription for prescribing a medicinal product, on the basis of which the medicinal product is supplied by the pharmacy;
(11) By an electronic prescription A prescription issued by a person entitled to prescribe a medicinal product by means of a data-processing device to be transferred to the centre and subject to the law on the electronic prescription (2011) ;
(12) With a prescription to be preserved A prescription that is left to the pharmacist for the patient to be supplied;
(13) With a prescription for drugs, A medical prescription issued by a doctor or a dentist with a prescription for the supply of drugs, issued by a doctor or a dentist;
(14) On the prescription of alcohol A prescription issued by a doctor or a dentist exclusively for the supply of ethanol (96 %) or mildly denatured ethanol;
(15) By telefax prescription A medical prescription sent by telefax to a doctor or dentist;
16) With a telephone prescription A medical prescription issued by a doctor or a dentist by telephone;
(17) With a pro auctore prescription A prescription in which a doctor, a dentist, an optician or a dental hygienist determines the medicinal product necessary for the exercise of his profession;
(18) With a medical order A written order issued by a doctor or a dental practitioner for the supply of a medicinal product to the hospital, the health centre, the operating unit of the private health service provider, or the Social Welfare Office; The doctor and the dentist must have the right to exercise their profession independently as a legal professional; the medical order is also signed by the hospital pharmacy or the medical centre of the medical centre in question; Article 62 of the (395/1987) And the order signed by the vessel owner's representative or master of the vessel to the ship pharmacies;
19) Renewal of the prescription (repetition) indication of the prescription by the prescriber of a medicinal product on prescription or by telephone, on the basis of which the pharmacy may re-dispense the medicinal products contained in the prescription;
20) With an iterated medical prescription A prescription which may be periodically reproduced on the basis of a prescription issued by the prescriber;
21) Drug exchange, For the exchange of a medicinal product prescribed in accordance with Article 57b of the Pharmaceutical Code; (20.12.2013/1129)
22) With alternative medicinal products Medicinal products whose active substances and their respective amounts are similar in biological terms and are included in the list to be established by the Agency for the Safety and Development of the Medicinal Products Agency; Medicinal products; and (20.12.2013/1129)
23) With a European prescription A prescription for prescribing a medicinal product in writing or by electronic means in the European Union or in a State belonging to the European Economic Area or in Switzerland, on the basis of which the other European Union or the European Economic Area A pharmacy in a participating State may submit the medicinal product to the patient. (20.12.2013/1129)
The right to prescribe medicinal products for a medical or medical purpose and a pro auctive prescription shall be exercised by a qualified person for the purposes of medical or medical purposes.
A doctor who provides additional basic health care shall have the right to prescribe medicinal products in accordance with paragraph 1. However, he does not have the right to obtain medicinal products with a pro auctore prescription.
A medical student acting on a temporary basis shall have the right to prescribe medicinal products only for patients treated with that function.
The person entitled to exercise the profession of dental practitioner independently is entitled to prescribe medicinal products for the purpose of dental or dentistry and a pro auctive prescription for the pursuit of his profession.
A dental practitioner who conducts a post-basic training exercise shall be entitled to prescribe medicinal products in accordance with paragraph 1. However, he does not have the right to obtain medicinal products with a pro auctore prescription.
In the case of a dental practitioner acting on a temporary basis, a student of dentistry shall be entitled to prescribe medicinal products only for patients treated in that function.
The dentist has the right to prescribe, at the same time, a maximum of 10 distribution units. Non-specialised dental practitioner may prescribe a pkv not more than the minimum marketing authorisation.
A certified nurse as well as a registered nurse and a midwife who has received a written order in accordance with Article 23b of the Law on the health care professionals is entitled to prescribe medicinal products from the pharmacy. In accordance with the written instructions received. Medicinal products subject to prescription, disease accounts and limitations of prescription have been defined Annex 1 . The formula of the written order is Annex 4. In general, the age of initiation or continuation of medication is related to the age of the child.
The medicine is determined by the nurse, the nurse and the midwife based on the active substance, strength and pharmaceutical form.
The optician may prescribe the medicinal products listed in Annex 2 to the dispensary with a pro auctore prescription.
Optician does not have the right to prescribe medicines to patients.
A self-employed dental hygienist may, by way of a pro auctore prescription, prescribe the medicinal products referred to in Annex 3 to the pharmacist.
A dental hygienist does not have the right to prescribe medicines to patients.
The medicine should be decided in agreement with the patient. The prescriber should provide the patient with adequate information on the use and use of the medicine.
Where appropriate, the prescriber should cooperate with pharmacists in pharmacies normally used by his patients in order to carry out medical counselling and safe, efficient and economical treatment of patients.
The prescriber may prescribe medicines only for a person whose medical needs have been confirmed by his or her own study or other reliable means. Special attention should be paid to the need for medication and to the efficacy, safety and price of the choice of medicinal product.
Where medicinal products are to be prescribed, the restrictions imposed by the marketing authorisation or otherwise imposed by the competent authority must be respected. The prescribing agent shall also take into account any recommendations for use.
The prescribing and renewal of a prescription requires that the prescriber has personally examined the patient during the previous year. However, a personal study is not required if, on the basis of patient documents or other information, the doctor or dentist can reliably verify the need for medical treatment. The nurse, the nurse or the midwife may only issue and renew the prescription on the basis of the need for a medicinal product which they have established.
Medicinal products must be prescribed in the form of equivalent quantities in the form of package sizes. If there are specific therapeutic criteria, an abnormal number of the standard packaging may be prescribed. For long-term treatment, treatment should be started with a small package and when the medicine has been shown to be suitable for the prescribed dose. The period of validity of the prescription may be limited by a separate indication 'per usum ad'.
Special care and care should be taken when prescribing a medicinal product suitable for the use of counterfeit medicines.
The prescriber should monitor, where possible, the actual use of the medicinal product to prevent the development of drug dependence. The treatment of patients with drug dependence should, as far as possible, be focused on one doctor.
Patients should not be prescribed medicinal products for misuse during the first reception, unless the prescription of the medicinal product is necessary. First-aid prescriptions shall be limited to the prevention of minor misuse.
For the purposes of determining the amount of the medicinal product, the forms shall be used in accordance with the formula established by the National Pensions Office for that purpose, subject to justified reasons.
The prescription should be written in a manual manual, typewriter or an automatic data-processing system. The prescription may contain only markings, abbreviations and corrections which cannot lead to misinterpretation. Corrections to the prescription shall be signed by an autograph, a clarification of the name and a date. If the prescriptions for the prescription of a prescription are full, it should not be renewed, but a new prescription should be drawn up.
The prescription shall not be used for prescribing a form to which the name of the medicinal product is preprinted or stamped. The prescription forms shall not be signed or labelled in advance. Forms and stamps should be kept in such a way that they cannot fall into the hands of the uninvolved.
The medicinal product should be labelled as follows:
1) the patient's name, date of birth or personal identification number and weight under the age of 12;
(2) the name or the trade name of the medicinal product or substances, the pharmaceutical form, the strength, the amount of the medicinal product or the duration of the medicinal product, in numbers or letters, or in both ways, a possible indication of the prohibition of the exchange of medicinal products; and The composition and quantity of the medicinal product to be manufactured in the pharmacy;
(3) the dose regimen of the medicinal product, the instructions for use and the type of medicine, i.e. whether the medicinal product should be used, if necessary or on a regular basis, as well as the intended use of the medicinal product, unless there are reasonable grounds for leaving it; and
(4) the place and date of the prescribing order, the individual signature of the prescriber, the identification number and the degree of instruction and, where appropriate, the speciality.
(20.12.2013/1129)If a doctor or dentist uses a name tag, it is sufficient, as provided for in paragraph 1 (4), that the identification number, as well as the knowledge and the specific area of the name, appear in the name of the name. (20.12.2013/1129)
In addition to the provisions of paragraphs 1 and 2, the European prescription shall include the direct contact details and the work address of the prescriber. In addition, the medicinal product should be prescribed by the name of the active substance. However, where the product is a biological medicinal product, the trade name of the medicinal product must be used in the prescription. The product name of the medicinal product may also be used for the medicinal product if the prescribing health professional deems it necessary for medical reasons. In such cases, the prescription shall briefly explain the reasons for the use of the trade name. (20.12.2013/1129)
Medicine and dentistry students should subscribe to the post, act or function and place of their place of prescription. The nurse, the nurse and the midwife shall mean the post, office or function and office of the medical order.
The prescription must be marked "Sic" if the prescriptor exceeds the prescribed dosing regimen in the approved spc or if the dose of the medicinal product ex tempore exceeds the authorised medicinal product The dose regimen or the maximum dose given in any other known source of origin.
When prescribing only one medicinal product is withdrawn from the screen for another medicinal product for another medicinal product.
The prescriber may send a prescription for a prescription issued by the National Pensions Office in accordance with Articles 12 and 13 to the pharmacy by telefax. The use of the Telefax prescription should be limited to specific situations only. Telefax prescriptions may be renewed and reissued.
The prescriptions of a telefax shall not prescribe any medicinal product to be preserved. Telefax may prescribe a medicinal product not more than the smallest packing.
The nurse, the nurse and the midwife shall not issue a telefax prescription.
The prescriber may give a prescription in person by telephone to the supplier to the supplier if there is a valid reason for the use of the telephone prescription. Also, when prescribing a telephone prescription, account must be taken of what prescribing and prescribing a medicinal product. The prescription must contain the same information as the written prescription.
Telephone prescriptions shall not be imposed on the telephone by telephone. The pkv may be prescribed by the telephone to a maximum of the smallest packing.
The nurse, the nurse and the midwife shall not issue a telephone prescription.
The prescription shall be valid for two years from the date of establishment or renewal. However, the prescriptions of the PkV medicinal product, the prescriptions of the drug drug and the pro auctore prescriptions shall be valid for only one year from the date of imposition or renewal.
Article 10 (4) provides for the limitation of the period of validity of the prescription.
With A 347/2015 Article 16 enters into force on 1 January 2017. The previous wording reads:
The prescription shall be valid for one year from the date of its imposition or renewal, unless the prescriber has limited the period of validity of the order within the meaning of Article 10 (4).
The prescriber should tell the patient that an alternative medicinal product can be changed to a cheaper product in the pharmacy. If the prescriber prohibits the exchange, the reasons for the prohibition shall be notified to the patient.
If the prescriber prohibits the exchange of the medicinal product, indicate the prohibition on the medicinal product for the medicinal product and its instructions. The exchange will be prohibited as 'no drug exchange'. The ban should not be entered in a prescription. The prohibition shall not be used in stamps and the prescription of medicinal products shall not be automatically added or proposed for prescriptions. If the prescriber wants to prescribe a medicinal product for a given marketing authorisation holder, the name of the medicinal product should be labelled, the name of the marketing authorisation holder and the indication of the prohibition.
The prescriber may restrict access to the medicinal product periodically by iteration, i.e. by ordering a medical prescription to be redelivered. For the purpose of infusions, the prescriptions shall be labelled "iter" (re-transmitted once), "iter bis" (re-transmitted twice) or "iter ter" (retransmitted three times).
The pre-delivery date may be re-marked with an early date by setting a minimum number of deliveries on days, weeks or months from the previous delivery. More than one year after the issuing of the order, it shall not be possible to reproduce the Iterofied prescription.
The following prescriptions may not be reproduced:
(1) the quantity submitted or renewed once and for all;
(2) keep the prescription;
3) pro auctore prescriptions;
(4) the telephone prescription;
(5) a European prescription.
(20.12.2013/1129)The prescription of a medicinal product may not exceed three times the prescribed prescription, unless the renewal is not prohibited by the term 'they rep'. The name and quantity of the new product should be indicated in the space reserved for new entries. The renewal marking must include the information contained in Article 13 (1) (4) and (2).
The prohibition on the exchange of medicinal products in accordance with Article 17 of the Medicinal Products Order does not apply to a renewed prescription. If the prescriber wants to ban the replacement of the medicinal product in the delivery of the new prescription, this shall be established by means of a 'no exchange of medicinal products' in the space reserved for renewal.
If the quantity or dosage of the medicinal product is changed, this should be indicated on the front page of the prescription form as well as in the case of renewal. The amendments shall be verified by signature, by name and by date. If new labelling can lead to confusion, a new prescription should be drafted instead of renewal.
The following prescriptions shall not be renewed:
(1) iteroted medical prescription;
(2) keep the prescription;
(3) telephone prescription;
4) a European prescription.
(20.12.2013/1129)The nurse, the nurse and the midwife cannot renew the prescription by phone.
The prescription of a medicinal product may be prescribed by a patient or a pro auctive prescription only by means of a confirmed narcotic drug application form or an electronic prescription. The actual substance shall not be prescribed by a European prescription. (20.12.2013/1129)
The 1961 Single Convention on Narcotic Drugs and List I of the Convention on Psychotropic Substances shall not be imposed.
Notwithstanding the provisions of paragraph 2, the prescriber may prescribe, as a special licence, the drugs listed in the 1961 Single Convention on Narcotic Drugs and List I of the Convention on Psychotropic Substances. Has specific therapeutic criteria.
The medicinal products for medicinal products must be kept in a space locked by the workstations. The health and social care unit shall record the number of the prescription form, the name of the patient, the identification number and the name of the prescriber.
The medicinal product can only be prescribed by a separate prescription if the medicinal product is to be stored:
(1) a condition is attached to the marketing authorisation; or
(2) The main active substances contained in the medicinal product are listed in a list established by the Agency for the Safety and Development of the Medicinal Products, which may only be supplied with a prescription and equipped with a prefix ZA Or PA.
The prescribed prescription shall be drawn up on a prescription form conforming to a formula established by the People's Pension Fund and shall not be renewed, itemised, prescribed by telefax or telephone. No other medicinal products may be prescribed in the same form. The medicinal product subject to a controlled prescription shall not be prescribed by a European prescription. (20.12.2013/1129)
The prescription may also be made by an electronic prescription to the patient.
The doctor may prescribe ethanol (96 %) and mildly denatured ethanol with a pro auctore prescription for medical and medical purposes, with the following restrictions:
(1) ethanol (96 %) of up to 4 000 ml per calendar year; the prescription shall be drawn up to the original bottle of 500 ml or less; ethanol (96 %) should be replaced by mildly denatured ethanol 9 and 12;
2) no other medicinal product should be prescribed in the same prescription.
The dentist may prescribe alcohol for the purposes of dental medical and medical purposes within the limits laid down in paragraph 1.
The doctor has the right to prescribe the dilutions of slightly denatured ethanol to the patient for external use.
The doctor has the right to prescribe alcohol-based medicines to patients. Medicinal products for internal use may contain not more than 20 % (m/m) ethanol if the main active substance in the mixture is something other than ethanol. Where it is necessary to use more than 20 % by weight of ethanol in order to dissolve or conserve the active substances, this percentage may be exceeded to the extent necessary.
The prescription of a special licence as referred to in Article 21f of the Medicinal Products Act requires that no other treatment is available for the treatment of the patient or that such treatment cannot be achieved with the desired result.
When prescribing a medicinal product requiring a special authorisation, the prescriber of a medicinal product shall, in addition to prescribing a prescription, report on the specific medical reasons for which the special authorisation is required. If the special authorisation is only used in a hospital, a health centre or a private health service provider, the patient does not need to be identified.
The prescriber of a medicinal product shall record all prescriptions issued and renewed in the medical file in such a way as to indicate that:
1) the date of issue of the prescription;
(2) the trade name or medicinal product or substances and strength of the medicinal product;
3. Packaging size;
(4) the possibility of retransmission;
(5) purpose and guidance; and
6) the reason for the prohibition if the prescriber has prohibited the exchange of medicinal products.
The prescriber should keep separate accounts for drug-related taxes, alcohol inorders and pro auctore prescriptions. The records shall contain the same information as the prescriptions. In the case of prescriptions written to the patient, the records shall include the diagnosis, the measures taken and the treatment provided.
On the basis of medical records and accounts, a report on the imposition of a medicinal product by the Social and Health Authorisation and Control Agency and the Regional Administrative Agency should be provided on request.
The operational unit shall have a method for monitoring prescriptions and for reporting and handling medication errors. Patients with long-term illnesses are treated in accordance with the law on the status and rights of patients (1999) The plan for the treatment of the patient, including treatment, organisation and timetable for implementation. (26/05/2013)
With A 347/2015 Paragraph 1 shall enter into force on 1 January 2017. The previous wording reads:
The operational unit shall have a method for monitoring prescriptions and for reporting and handling medication errors.
A nurse, health care and midwife and a medical student must be able to consult independently of a legitimate medical practitioner and a dental practitioner independently of a legitimate dentist. In matters relating to prescribing medicinal products. If the patient receiving treatment requires medical treatment, which is not prescribed by a nurse, nurse or midwife, or if the patient's treatment requires a medical evaluation, the patient should be provided with a doctor's office within a reasonable period of time.
The nurse, the nurse and the midwife, as well as the medical and dentistry, must comply with the patient's written treatment plan and the health care unit's national treatment recommendations. Instructions.
The electronic prescriptions shall be drawn up in accordance with the laws and regulations governing the electronic prescriptions (485/2008) And, where appropriate, the provisions of this Regulation.
The provisions of Article 19 of this Regulation shall not apply to the electronic prescription.
This Regulation shall enter into force on 1 January 2011.
This Regulation repeals the Decree of the Ministry of Social Affairs and Health of 6 August 2003 on prescribing medicinal products (2003) .
This Regulation shall enter into force on 1 January 2014.
This Regulation shall enter into force on 1 January 2017.
