Regulations relating to requisition and provision of medicines from pharmacies
Date FOR 1998-04-27-455
Ministry of Health and Care Services
Published In 1998 550 (Annex II substitution list omitted)
Commencement 01/07/1998
Edited
FOR-2015-12-17-1708 from 01/01/2016
Changes
FOR-1993-11-11-1021
For
Norway
Legal
LOV-1992-12-04-132-§2, LAW-1992-12-04-132-§8, LAW-1992-12-04-132-§22, LAW-1992-12-04- 132-§25b, TO-1995-06-08-521, LOV-1999-07-02-64-§11, LOV-2000-06-02-39-§6-6, LAW-2000-06-02 -39-§6-8, LOV-2001-06-15-75-§17, LAW-2003-12-19-124-L-29, TO-2003-12-19-1790
Promulgated
Corrected 01.03.2006 (§ 2-5 and § 2-7 notes)
Short Title
Regulations on drugs from pharmacies
Chapter Overview:
Chap. 1. General provisions (§§ 1-1 - 1-5)
Chap. 2. The right to requisition. (§§ 2-1 - 2-11)
Chap. 3. Requisition by prescription or requisition (§§ 3-1 - 3-10)
Chap. 4. Standard Information on prescription or requisition (§§ 4-1 - 4-6)
Chap. 5. Completion of prescription or requisition. (§§ 5-1 - 5-11)
Chap. 6. Receipt of prescription or requisition (§§ 6-1 - 6-5)
Chap. 7. Expedition of prescriptions and requisitions. (§§ 7-1 - 7-4)
Chap. 8. Delivery of prescription drugs and requisition (§§ 8-1 - 8-7)
Chap. 9. Collect and storage of prescriptions, etc. (§§ 9-1 - 9-5)
Chap. 10. Disclosure of drugs without a prescription (§§ 10.1 - 10.4)
Chap. 10a. Control of drugs before dispensing (§10a-1)
Chap. 11. Shipment of drugs (§§ 11.1 - 11.3)
Chap. 12. Marking the provision of medicines (§§ 12-1 - 12-9)
Chap. 13. Entry into force. Specific provisions (§§ 13.1 - 13.5)
Annex I (Repealed)
Appendix II. Changing List
Appendix III: List of drugs in prescription group A and B as fish health biologists may requisition
Adopted by Health and Social Affairs (now the Ministry of Health) on 27 April 1998 pursuant to the Law of 4 December 1992 No.. 132 on medicines etc. (Medicines Act) § 2, § 8, § 22, § 25b cf. Royal Decree. of 8 June 1995 no. 521, law of 2 July 1999 no. 64 relating to health (Health) § 11, Law of 2 June 2000 no. 39 on pharmacy (Pharmacy Act) § 6-6 second paragraph and § 6- 8 and the law of 15 June 2001. 75 of veterinarians and other animal health § 17.
Added basis: law 19 December 2003 no. 124 of food production and food safety. (Food Act) § 29 subsection. Delegated Decision of 19 December 2003 no. 1790.
Changes: Amended by regulations 22 Dec 1999 no. 1559, 27 April 2000. 364, November 16, 2000 No.. 1155, 27 Dec 2000 no. 1581, February 26, 2001 No.. 196, Sept. 4, 2000 No.. 895, 1 March 2001 No.. 250, april 1, 2002 no. 377, May 31, 2002 No.. 511, 7 October 2002 No.. 1154 (legal) 1 Jan 2002 no. 1780, 19 Dec. 2002 No.. 1714, March 17, 2003 no. 423, March 28, 2003 no. 425, May 15, 2003 No.. 666, February 17, 2003 No.. 225, June 13, 2003 no. 719, 26 June 2003 No.. 866, 15 August 2003 No.. 1065, 1 September 2003 No.. 1111, 21 July 2003 No.. 983, October 24, 2003 No.. 1311, 10 November 2003 No.. 1374, 1 Jan 2003 no. 1719, February 17 2004 no. 463, March 11, 2004 no. 570, 17 Dec 2003 No.. 1725, 15 april 2004 No.. 664, May 10, 2004 No.. 771, June 15, 2004 no. 957, 11 August 2004 No.. 1205, August 30, 2004 no. 1226, September 15, 2004 no. 1276, October 23, 2004 No.. 1400, 29 November 2004 No.. 1510, 26 January 2005 No.. 49, February 22, 2005 No.. 161, February 18, 2005 No.. 167, March 22, 2005 No. . 264, 25th april 2005 no. 349, May 31, 2005 No.. 545, September 8, 2005 No.. 1012, 17 January 2006 No.. 38, February 9, 2006 No.. 197, February 23, 2006 No.. 274, February 7, 2007 No.. 222, June 28, 2007 no. 815, 21 Dec 2007 no. 1610, april 3, 2008 No.. 320, May 9, 2008 no. 503, 18 Dec 2009 No.. 1641, 17 Dec 2009 No.. 1701, 18 Dec 2009 No.. 1839 , July 3, 2009 No.. 974 (as amended by regulations 22 October 2009 No.. 1312 and June 24, 2010 no. 985), November 2, 2010 No.. 1399, 16 Dec 2011 No.. 1396, 17 January 2013 No.. 61, February 14 2013 No.. 242, 20 August 2013 No.. 1037, 18 Dec 2014 No.. 1833, 11 June 2015 No.. 644, March 22, 2015 no. 276, 17 Dec 2015 No.. 1708.
Corrections: 09.07.2002 (§ 2-5), 09.09.2002 (Annex I), 03.05.2005 (Annex II), 01/03/2006 (§ 2-5 and § 2-7 notes).
Chap. 1. General Provisions
§ 1-1. Purpose purpose of these regulations is to ensure proper requisition of medicine, proper handling of prescription or requisition in pharmacies and proper provision of medicines from pharmacies.
§ 1-2. Scope The regulations governing prescriptions for drugs, expedition of prescription or requisition in pharmacy and dispensing of medicines from pharmacies.
§ 1-3. Definitions In this regulation:
A)
Drug, substance, drug, composition etc as mentioned in legemiddelloven1 § 2, first paragraph. Regulations pursuant to the Medicines Act § 2, second paragraph; 2
B)
Approved drug: drug with marketing authorization in Norway;
C)
Prescription: ordering medication to use for specific people or animals, or for use in requisitioner practice;
D)
Requisition: different order of drug than by prescription;
E)
Requisition (requisition): oral, written or electronic order drug by prescription or requisition;
F)
Consignor: natural or legal person with the right to prescribe drugs;
G)
Reiterasjon: reseptutsteders endorsement by prescription that a drug can be dispatched and delivered several times;
H)
Expedition (dispatch): pharmaceutical control and istandgjøring drug according to the prescription or requisition;
I)
Extradition: extradition of drug from pharmacy to your prescriber, patient, customer, animal owner or institution.
§ 1-4. Basic requirements by requisitioning, expedition and delivery Requisitioner shall have procedures that ensure proper requisition of medicine, which contributes to proper receipt and handling of prescription or requisition and conducive to proper dispensing medicine from the pharmacy.
Patient or animal owner shall be allowed to choose at which pharmacy prescription will be dispatched.
Pharmacies must have procedures to ensure proper receipt and handling of prescriptions and requisitions and ensuring proper provision of medicines.
§ 1-5. Expedition Straight to dispatch medicines by prescription or requisition has pharmacists with ekspedisjonsrett1 in Norway.
Chap. 2. The right to requisition.
§ 2-1. 'Right to requisition Doctor with Norwegian authority has the right to prescribe drugs. For other groups of doctors following rules apply:
A)
Physician license for medical practice in Norway, with the limitations imposed by the license, require medicinal to the extent necessary for the exercise of his or her service.
B)
Physician authorized in a Nordic country, as well as doctors who meet the conditions for providing service in Norway in accordance with Regulation 8 October 2008 no. 1130 at authorizations, licenses and specialist training for health workers with professional qualifications from other EEA -land or from Switzerland, can prescribe medicines in the prescription group group B and C in Norway to the pertinent regulations. The scheme does not phone prescriptions or electronically transmitted prescriptions, including fax prescriptions.
C)
Finnish and Swedish public physician service in medical district bordering Norway has general license to practice medicine in adjoining Norwegian municipalities, and can prescribe drugs in any recipe groups in accordance with the provisions of Chapter 3. For drugs in prescription group A required not authorized form.
Drugs in prescription group A can only be ordered by:
A)
doctors with Norwegian authorization
B)
doctors with license in Norway for business in a senior position at the hospital,
C)
doctors with license in Norway for business in position as municipal or as a substitute for practitioner,
D)
interns and other similar license, and
E)
other doctors who have applied have been granted such right of requisition of Health.
For doctors the right to requisition otherwise apply including the following limitations and special rules:
A)
Medicines can only be requisitioned for human medical use.
B)
Medicines can only be ordered in accordance with regulations about which prescription medicines that will have a limited requisition, cf. Regulations on drugs § 7-4, second paragraph.
C)
Drugs Containing methadone can only be requested for the individual patient when treatment is initiated in hospital as part of pain treatment, or when the criteria for medically assisted treatment by drug abuse are fulfilled, ref. D.
D)
Drugs used for substitution treatment of drug addiction can only be requested for the individual patient in the following cases:
1.
If the person is granted a mat in the specialist health services, cf. Regulation of 18 December 2009 No.. 1641 on mat § 5, or
2.
As part of a short, clearly defined and interdisciplinary reduction plan that has been prepared in cooperation with the specialist.
Requisitioned physician must ensure that the above conditions are met and the necessary information that confirms this on the prescription.
E)
Liquor aerated drugs can only be ordered in accordance with regulations on liquor, including alcohol, and wine for medical bruk.2
F)
By requisition of medicinal product in Norway doctor should give a medical justification for the requisition, including why medicines that have marketing authorization in Norway can not be used.
§ 2-2. Tooth 'right to requisition Dentist with Norwegian authorization or license has, with the restrictions that are imposed, the right to prescribe the medicines that are necessary for the exercise of Dentist business.
For dentists the right to requisition These include the following general restrictions and special rules:
A)
Medicines can only be requisitioned for human medical use.
B)
Medicines can only be ordered in accordance with the prescribing and dispensing regulations for that prescription.
C)
Liquor aerated drugs can only be ordered in accordance with regulations on liquor, including alcohol, and wine for medical bruk.1
D)
By requisition of medicinal product in Norway shall dentist give a medical justification for the requisition, including why medicines that have marketing authorization in Norway can not be used.
For patients dentists have the right to prescribe the necessary drugs associated with dental care and prevention and treatment of disease of the oral cavity or adjacent tissue. When it comes to drugs in prescription group A and B, the following drugs requisitioned in dosed form for oral and rectal use:
A)
morfin-, petidin- and dekstropropoksyfenpreparater, more than 20 pieces;
B)
codeine-containing analgesics in ATC group N02;
C)
anxiolytics in ATC group N05B, smallest package approved drug, more than 25 pieces;
D)
hypnotics and sedatives in ATC group N05C maximum of 10 pieces;
E)
cough suppressants in prescription group B, smallest package approved drug.
For use in practice dentists to prescribe these drugs in prescription group A:
A)
dextropropoxyphene tablets, more than 20 pieces;
B)
morphine and pethidine as ampoules or in dosed form for oral or rectal use, more than 20 pieces.
C)
flunitrazepam tablets, more than 50 pieces.
Directorate of Health decides in cases of doubt which drugs the right to requisition under this section applies.
Dentists may in special cases on application be extended right to requisition. Such an application is decided by the Directorate of Health.
Provision applies equally to dentists who meet the conditions for providing services in Norway in accordance with Regulation 8 October 2008 no. 1130 at authorizations, licenses and specialist training for health workers with professional qualifications from other EEA countries or from Switzerland.
§ 2-3. Veterinarians right to requisition Veterinary with Norwegian authorization or license has, with the restrictions that are imposed, the right to prescribe the medicines that are necessary for the exercise of veterinary operations, including requisition to animal owners for animals. The same applies to veterinarians who meet the conditions for providing services in Norway in accordance with the Regulation on 19 January 2009 No.. 77 on the right to work as animal health or semi personnel under the EEA Agreement.
Veterinary Students are permitted to perform assistant service by practicing veterinarian can prescribe drugs to the extent necessary for the performance of duty. Students' right to requisition does not include medicines in the prescription group A.
for veterinarians entitled to requisition These include the following limitations and special rules:
A)
Medicines can only be requisitioned for veterinary use.
B)
Liquor aerated drugs can only be ordered pursuant to the regulations on liquor, including alcohol, and wine for medical bruk.1
C)
Medicines should be ordered as ready to use formulation, cf. § 3-8.
D)
By requisition of medicinal product in Norway shall vet give a medical justification for the requisition, including why medicines that have marketing authorization in Norway can not be used.
When selecting drugs to treat animals Regulations of 16 January 2007 no. 50 on the use of veterinary medicines.
In special cases, the Norwegian Medicines Agency for application in an individual case the right to requisition of rensubstans.
§ 2-4. Pharmacists the right to requisition Pharmacists expedition in Norway may prescribe drugs to pharmaceutical department at the hospital, cf. Regulations on medication management for businesses and health professionals who provide health care.
§ 2-5. Public health nurses and midwives requisitioning health nurses can prescribe vaccines in accordance with the approved vaccination program, cf. Regulations on medication management for businesses and health professionals who provide health care.
Nurses health nursing and midwifery authorization or license under the Act 2 July 1999 no. 64 relating to health personnel, given the right to prescribe all kinds of contraceptives for women from age 16, as well as medicines for use in practice as necessary administration of contraceptive agents.
It is required that a nurse with public health nursing and midwifery has completed relevant education topics cohabitation, sexuality and contraception, and that the individual has id number as nurse health nursing or midwife in the public Health Registry.
§ 2-6. The right to requisition for drivers etc. of ships, fishing vessels Driver, shipping or doctor who had to be employed on board, can prescribe medicines that will be aboard the ship according to skipsmedisinforskriften.1
Shipyards and company producing rescue equipment for ships , ref. ships medicine regulations, may on the basis of special permit from the Directorate of Health prescribe drugs to settlers. Directorate of Health may impose conditions for such a permit.
§ 2-7. The right to requisition for pilot and flight commander in airline commander and flight commander in commercial air aviation enterprise (airline) can prescribe medicines to be aboard the aircraft in accordance with airline the enterprises its provisions ref. Luftfartsloven1 § 6-2 and forskrift2 first aid equipment in aircraft.
§ 2-8. Tannpleieres right to requisition dental hygienist with Norwegian authorization or license has the right to prescribe these drugs to the extent necessary for the practice of dental hygienist business:
A)
agents against caries,
B)
overflateanestetika for dental use,
C)
antiseptics for local treatment in the mouth.
Dental hygienist with Norwegian authorization or license and recognized education in the use of injectable local anesthetics may also prescribe these drugs to the extent necessary for the practice of dental hygienist business:
A)
funds for local infiltration anesthesia for dental use,
B)
adrenaline solution in an auto-injector for use against anaphylactic shock.
Dental hygienists can only prescribe medicines for use in practice.
§ 2-9. Requisition for local drug store manager of the agency as defined in Regulation 3 April 2008 no. 320 on medication management for businesses and health professionals providing health care to requisition (order) drugs for local drug store in accordance with the list approved by the doctor. Company manager may delegate this task to the same regulations § 9.
provision in § 2-1 second paragraph does not preclude that there may be requisitioned drugs in prescription group A Pharmaceutical stock.
§ 2-10. Practitioners' right to requisition Optometrists authorization or license, who are trained in the use of diagnostic drugs either in their primary education or in the form of additional education confirmed by the issuance of evidence from Norwegian Opticians Association may prescribe eye drops for diagnostic use. The Norwegian Medicines Agency determines which eye drops covered by this provision. Said optometrists can prescribe adrenaline in the form Norwegian Medicines Agency stipulates.
§ 2-11. Fiskehelsebiologers right to requisition Fiskehelse Biologists with Norwegian authorization or license has, with the restrictions that are imposed, the right to prescribe drugs for aquatic animals except mammals, including requisition to animal owners for the use of aquatic animals except mammals. When it comes to drugs in prescription group A and B, drugs requisitioned according to supplied liste.1
For fiskehelsebiologers right to requisition These include the following limitations and special rules:
A)
Medicines can only be requisitioned for veterinary use.
B)
Medicines should be ordered as ready to use formulation, cf. § 3-8.
When selecting drugs to treat animals Regulations of 16 January 2007 no. 50 on the use of veterinary medicines.
In special cases, the Norwegian Medicines Agency for application in an individual case the right to requisition of rensubstans.
Chap. 3. Requisition by prescription or requisition
§ 3-1. Written requisition Prescription and requisition shall be submitted in writing, unless the conditions are met for oral requisition or requisition by fax.
Requirement for written form is not an obstacle to electronic communications of prescription or requisition, if used an adequate method that authenticates the sender and ensures the prescription or requisition content. The ministry may impose special requirements for electronic communications by requisition of medicine.
Prescription set forth in writing can reitereres unless the prescription concerns drug in the prescription group A or B, ref. § 3-5 and § 3-6.
§ 3-2. Spoken requisition If it is impracticable to require in writing, the prescription or requisition is made orally. Spoken requisition can happen in person or by phone (prescription). For requisitions applies only requisition by telephone.
There are only applicant personally who can prescribe drugs orally.
Prescription put forward orally can not reitereres.
§ 3-3. Use of fax transmission of prescription or requisition by fax can only happen if requisitioner confidentiality is not an obstacle to it.
Requisitioner utilizing fax obliged to have procedures for safe transfer.
Original of prescription / requisition transmitted by facsimile is not valid for the expedition.
Prescriptions transmitted by facsimile can not reitereres.
§ 3-4. Limitation Prescription and requisition-barred one year after the issuance date. Reiterasjon on prescription-barred one year from reiterasjonsdato.
Prescriptions and reiterating rations on hormonal contraceptives barred three years from the date the prescription is issued or reiterert.
§ 3-5. Exemptions and special provisions relating to prescription group A Upon requisition of medicine in prescription group A the following exceptions and special rules:
A)
prescription is valid for one-time expedition.
B)
The prescription may not reitereres except requisition for national expense.
C)
Other oral requisition than by telephone does not apply.
D)
When using telephone prescription can only smallest standard package or an amount equivalent to a normal therapeutic dose in three days is required.
E)
Requisition by fax can not be used. An exception is the ship in international trade.
F)
Electronic communication of prescription can only happen via Prescription Intermediary.
§ 3-6. Exemptions and special provisions relating to prescription Group B Upon requisition of medicine in prescription group B the following exceptions and special rules:
A)
prescription is valid for one-time expedition.
B)
The prescription may not reitereres except requisition for national expense.
C)
Other oral requisition than by telephone does not apply.
D)
using telephone or facsimile, only the smallest standard package, or an amount equivalent to a normal therapeutic dose in seven days, requisitioned. Upon requisition by telephoning hospitals mm, larger gaskets requisitioned if shareholders and the institution is known pharmacy.
§ 3-7. Exemptions and special provisions relating to prescription Group C Upon requisition of medicine in prescription group C the following exceptions and special rules:
A)
prescription is valid for one-time expedition.
B)
The recipe can reitereres, except for prescription submitted orally or transmitted by fax.
§ 3-8. Use Finished medicines Prescription medicines should be ordered as ready for use formulations with less drug durability prevents this.
§ 3-9. (Repealed)
§ 3-10. Issuance of EEA prescriptions for medicines for human When a patient reports that prescription planned to be used for dispensing a drug to people in another country in the EEA, duties Norwegian consignor to ensure that the prescription meets the following requirements:
A)
identification of the patient with full name, surname and date of birth,
B)
date of issue of the prescription,
C)
identification of applicant with full name, surname and job title
D)
requisitioner contact details in the form of e-mail, phone and fax numbers with area codes, work address and country,
E)
handwritten or electronic signature
F)
identification of the type of pharmaceutical drug with generic name mentioned in regulation on 18 December 2009 No.. 1839 drugs § 3-26, or trade name if requisitioned medicine is a biological drug or applicant believes that the use of trade names medically necessary and a brief explanation for this,
G)
pharmaceutical form, quantity, drug strength and dosage.
Chap. 4. Standard Information on prescription or requisition
§ 4-1. Common rules information on prescription form and requisition forms should be so complete that confusion with other Requisitioner avoided.
The information shall normally be printed or stamped form. Exceptionally, information should nevertheless be applied typed or written in block letters.
At oral requisition and electronic requisition, re. §§ 3-2 and 3-3, the provisions of §§ 4-2 and 4-3 equivalent.
Interns, medical students and others with similar license for operations subordinate doctor or as assistant to practitioner must use the hospital or responsible doctor prescription form by requisition of medicine in all prescription groups.
§ 4-2. Standard information on prescription forms Prescription Form shall always disclose reseptutsteders:
A)
name
B)
Id number according to the Health Registry,
C)
profession
D)
address (work)
E)
phone number (work).
As prescription forms are also heal ordination card el dose dispensing.
Health Directorate may exempt specific categories of prescribers from the requirement in subsection b.
§ 4-3. Standard information on requisition forms Requisition form must be applied:
A)
institution's name,
B)
department's name.
§ 4-4. Standard additional information by fax forms Prescription / requisition transmitted via fax shall be printed or stamped "Fax Prescription / Fax Requisition" before it is transferred to the pharmacy.
§ 4-5. Authorized form of requisition of medicine in prescription group A Prescription for medicine in prescription group A should be written on the form, authorized by the Health Directorate of the individual prescriber. For Finnish and Swedish government doctors with service in the medical district bordering Norway required not authorized form.
It does not require authorized form of requisition of medicine in prescription group A to hospitals and nursing homes, etc.
§ 4-6. Prescription for fish medication, etc. Prescription for all fish medication etc. (Broodstock, eggs, fry, fingerlings, fish, shellfish, etc.) Should be written on the form determined by the Directorate of Health.
Health Directorate may grant exemptions from this provision.
Chap. 5. Completion of prescription or requisition.
§ 5-1. Basic requirements Prescriptions and requisitions must contain all information necessary to ensure proper handling and proper use of medicines.
Prescriptions and requisitions concerning veterinary medicines must contain all the information to be reported pursuant to the regulations on 3 July 2009 No.. 971 on reporting of information on dispensed and used drugs for animals § 3.
§ 5-2. Requirements for clarity, dating and signing Prescription and requisition shall be formulated clearly, dated the day it is issued and single-handedly signed by the consignor.
Fax Prescription / -rekvisisjon shall in addition to requisitioner own handy signature have another confirmation of the sender's identity.
For other electronic requisitioning replaced singlehandedly signature with other unambiguous and secure identification of the consignor.
§ 5-3. Prescriptions issued by a veterinarian and surgeon prescription issued by veterinary surgeon should always be applied either "For animal", "Do" or "VM".
§ 5-4. Requisition for use in their own practice By requisitioning for use in requisitioner practice written "For use in practice" or similar on prescriptions.
§ 5-5. Reiterasjon Reiterasjon be printed with numbers and letters. Reiterasjonen only apply the drug during which the printed and no other drugs in the same prescription.
§ 5-6. Restrictions on the right to use the same prescription medicines to more people or more animal species can not be requisitioned for the same prescription.
By requisition of medicine in prescription group A and B may not be requisitioned drugs in other prescription groups on the same prescription.
§ 5-7. Information on patient Prescriptions must bear the following information about the person medicine is requisitioned for:
A)
First,
B)
surname,
C)
gender,
D)
national identity and
E)
address.
Before prescription issued on drug in the prescription group A or B, the credentials required and presented if the patient is unknown to prescription issuer.
Dob required not applied to people who are not assigned ID number. If the person has personal identification, unless this is available by prescription issue, your doctor may issue a prescription if it is considered necessary that the person receiving the drug.
§ 5-8. Information on animal owners and animal species Pet Owner's name and species and adequate identity of the animal medicine has been requisitioned for, must bear the prescription. Upon requisition of drug in the prescription group A and B shall also pet owner's birth date and year, and address applied.
Before prescription issued on drug in the prescription group A or B, the credentials required and presented if the animal owner is unknown for prescription issuer.
§ 5-9. Information on drug should be on the prescription given sufficient information about the drug, its dosage form, strength or composition and quantity such that the prescription can be dispatched correctly. Rather amount of the drug, dosage and duration of treatment is indicated.
By requisitioning of drug in the prescription group A, the amount of the drug is indicated both by numbers and letters.
By requisition of drug should especially high or unusual dosage, including by exceeding the maximum dosage specified in the approved SPC, written with numbers and letters.
§ 5-10. Information on drug use Application and complete directions for use shall if possible be set on the prescription.
By requisition of ex tempore prepared solution must be administration indicated on the prescription.
§ 5-11. Information on withdrawal and start time limit when it requisitioned drug to animals involving withdrawal of supply of eggs, milk, honey or slaughter, the period shall be stated on the prescription.
When the animals participating in competition requisitioned drug involving grounded a period shall start deadline indicated on the prescription.
Chap. 6. Receipt of prescription or requisition
§ 6-1. Pharmacist Control Any prescription or requisition shall be considered and approved by a pharmacist.
§ 6-2. Receipt of telephone prescriptions Telephone Prescriptions must be received by pharmacist and recorded in writing in a way that enables a total control after the last year of phone prescriptions, ref. § 9-3.
Phone Prescription for medicine to fish etc. shall be reduced on a special form prescribed by the Norwegian Medicines Agency. Apoteket has a duty to send a copy of all such prescriptions to the instans1 determined by the Norwegian Medicines Agency. The Norwegian Medicines Agency may grant exemptions from this provision.
§ 6-3. Checking the physician's identity Pharmacies receiving oral prescription or requisition, including by telephone and electronically transmitted prescriptions, including fax prescription shall have procedures for controlling the physician's identity.
When using telephone prescription drugs in the prescription group A and B should the identity be checked if the applicant is not known to the pharmacist.
§ 6-4. Control of prescription and requisition Apoteket shall promptly provide the information necessary to ensure safe handling and proper use of the drug if:
A)
prescription or requisition is not presented in accordance with the provisions of Chapter 3, 4 and 5;
B)
there is doubt about the interpretation of the prescription or requisition;
C)
there is reason to believe that the applicant has committed errors.
§ 6-5. Control of prescriptions authenticity If there is doubt that a prescription is true, this must be clarified before the drug dispensed.
Special care must be taken when receiving prescriptions for drugs in prescription group A and B and other drugs that can be abused.
Chap. 7. Expedition of prescriptions and requisitions.
§ 7-1. Information that must be applied to prescription At each expedition of prescription drug shall prescription applied price, date, pharmacists own handy receipt and the pharmacy stamp (identification).
Is it for the manufacture of prescription drugs used excipients that are not prescribed by applicant, the name and quantity of these are recognized on the prescription.
§ 7-2. Information that must be applied requisition etc. By expedition of requisition and prescription cards, etc. for dose dispensing is sufficient that pharmacists receipt recorded at once.
§ 7-3. Expedition of inadequate prescription etc. (nødekspedisjon) When considered necessary and prescription issuer can not meet, the pharmacist dispatch medicines once by prescription that is worded in violation of any provision of Sec. 3, 4 and 5. The same applies if the prescription or reiterasjonen is obsolete, ref. § 3-4, and also if the patient does not possess prescription at shipping point.
By expedition under subsection shall not be divulged greater amount of drug than necessary until prescription issuer may be made and rectify the fault.
Expedition under this section shall be documented separately in the pharmacy, ref. § 9-4 and applied the prescription if a prescription has served as a basis for nødekspedisjonen.
§ 7-4. Expedition of EEA prescriptions Prescriptions issued by a person with the right to prescribe drugs to people in an EEA country, can be dispatched by a Norwegian pharmacies. The prescription must meet the requirements specified in § 3-10 first paragraph a to g.
Prescription issued by a veterinarian with the right to prescribe medicines for animals in an EEA country must meet the requirements specified in Sec. 3, 4 and 5. Application of Id-number, ref. § 4-2 subsection b, is not required.
If there is reasonable doubt about prescription authenticity, content or comprehensibility, the pharmacist refusing to expedite the prescription.
The prescription must be for a drug in the prescription group C which has marketing authorization in Norway in accordance with Regulations 18 December 2009 No.. 1839 medicinal ch. 4, 5 or 6
Phone Prescription and telefax prescription may not be dispatched.
Chap. 8. Delivery of prescription drugs and requisition
§ 8-1. Claims for prescription or requisition Prescription medicines can only be dispensed by prescription or requisition that are drawn up in accordance with the requirements set forth in Sec. 3, 4 and 5.
requirement for a prescription does not apply if the conditions for nødekspedisjon exist, cf. § 7-3.
§ 8-2. Information about medicine pharmacy will help ensure that the person receiving drugs have adequate information on the product that it can be used properly.
§ 8-3. Due diligence requirements for drugs that can be abused Particular care should be exercised when delivery of medicines in the prescription group A and B and other drugs that can be abused.
Identification, authorization, or other confirmation of identity may be required at delivery of such drugs, and should be required when the client is not known to the pharmacist.
Identification, authorization, or other confirmation of identity may also be required if there is doubt about the data contained on the prescription is correct or if there is doubt about requisitioner identity.
Assessed it likely that the drug will be abused, the drug must not be disclosed before it is conferred with prescription issuer.
§ 8-4. Drugs with specific requirements for extradition and / or requisition Upon submission must pharmacist ensure that the disclosure is not contrary to regulations about which prescription medicines that will have a limited disclosure, cf. Regulation on medicines § 7-4 first paragraph.
When providing drug commandeered by drug § 2-5, must pharmacist ensure that the conditions for such requisition is fulfilled and that there are provided medical justification for the requisition, including why medicines that have marketing authorization in Norway can not be used.
§ 8-5. Measuring Instrument for liquid pharmaceuticals liquid medicines for oral use be dispensed with appropriate measuring instrument.
The requirement in subsection does not apply to veterinary preparations for flock treatment.
§ 8-6. Premix for Medicated Premix for medicated feed should only be issued to approved manufacturer in accordance with Council Directive / 90/167 / EEC on medicated and regulations 28 June 1996 no. 693 on prescribing, manufacturing and distribution etc. of medicated feed to animals, birds, fish and other aquatic organisms.
§ 8-7. Interchangeable drugs as interchangeable drugs are considered the drugs that are listed on the Exchange List.
Swap list determined by the Norwegian Medicines Agency and comes as part of these regulations.
Chap. 9. Collect and store prescriptions etc.
§ 9-1. Dispensing of prescriptions prescription should be disclosed while the drug delivered to the recipient, unless otherwise indicated in this chapter. Can prescription not disclosed, should patient or animal owner made aware of it.
§ 9-2. Storage etc. of prescriptions prescription group A and B Prescription for medicine in prescription group A and B shall be retained by the pharmacist for expedition and kept for at least five years (prescription group A) and at least one year (prescription group B).
§ 9-3. Storage of telephone, facsimile and computer-based requisitioning etc. Apoteket documentation for receiving telephone prescriptions shall be kept for one year. Telephone prescription may not be disclosed to the patient or animal owner.
Fax Prescriptions, telefaksrekvisisjoner and other electronically transmitted prescriptions can not be extradited.
Ministry may impose specific requirements for the storage of computer-based prescription data. It also applies to prescriptions and requisitions are transferred electronically.
§ 9-4. Documentation of nødekspedisjon Apoteket documentation expedition accordance with § 7-3 (nødekspedisjon) shall be kept for one year.
§ 9-5. Submission of stored prescriptions, etc. Upon request, the pharmacy send prescriptions and / or prescription information to the Norwegian Medicines Agency, the Norwegian Board of Health or the County.
Chap. 10. Disclosure of drugs without a prescription
§ 10-1. Disclosure of non-prescription medicines Non-prescription medicines can be delivered without prescription. The same applies to prescription drugs, in limited quantities are exempt prescription.
§ 10-2. Information about drug Upon delivery of drugs without a prescription should pharmacist in particular ensure that:
A)
drugs are provided with adequate information on the use, storage and shelf life;
B)
customer has sufficient information about the medicines that they can be used properly;
C)
disclose the possible harmful effects, especially if there is reason to believe that the drug will be misused.
§ 10-3. Price information for the purchase of patient or animal owner should pharmacist give information about cheaper alternatives if there are price differences of significance.
§ 10-4. Due diligence requirements for drugs that can be abused Medicines may be supplied without a prescription, have not disclosed when it is considered likely that it will be abused.
Chap. 10a. Control of drugs before dispensing
§ 10a-1. Control of drugs before dispensing pharmacy shall, before dispensing medicine confirm the drug's authenticity using the safety devices referred to in regulation on 18 December 2009 No.. 1839 drugs § 3-29.
Chap. 11. Shipment of drugs
§ 11-1. Due diligence requirements for shipment Shipment of medicines must be such as to ensure that they come to the correct recipient, and that they are undamaged and without loss of quality.
§ 11-2. Drugs that require special storage conditions Upon shipment of medicine that require special storage conditions, must be taken of the requirements for storage of packaging and assessment of carrier delivery and shipping.
§ 11-3. Dispensing of drugs When providing drugs for shipment shall be required documentation that the right person receives the drugs.
Chap. 12. Marking the provision of medicines
§ 12-1. General rule When providing drug should be ensured that it is adequately marked to ensure:
A)
identification of preparation;
B)
identification of manufacturer;
C)
proper storage;
D)
proper use.
In addition, the drug upon delivery be labeled in accordance with the provisions of this chapter.
§ 12-2. Drugs dispensed by prescription directly to the patient or animal owner Medicines dispensed by prescription, should be labeled:
A)
patient's name or pet owner's name and animal species;
B)
requisitioner name and profession;
C)
date of delivery;
D)
pharmacy's name.
Usually the drug should also be applied to application and use counsel as this emerges from the prescription. If complete directions for use can not be applied to "Use as agreed with ..... 'El applied.
Pharmacists receipt shall be applied, unless safety considerations expedition documented safeguarded otherwise.
§ 12-3. Drugs delivered to the consignor Medicines dispensed by prescription to the applicant, should always be labeled with:
A)
pharmacy's name;
B)
extradition date.
Pharmacists receipt shall be applied, unless safety considerations expedition documented safeguarded otherwise.
§ 12-4. Medicines dispensed for use in hospitals and nursing homes, etc. Additional labeling according to §§ 12-6 - 12-9 applied medicines for use in hospitals and nursing homes etc by arrangement with the institution.
Following additional labeling should always be performed, although it is not agreed:
A)
Marking as mentioned in § 12-7 letter e (for caustics) and letter f (for flammable and explosive agents) should always be applied.
B)
Drugs in prescription group A shall be specifically marked, for example. "In the poison cupboard" or poison label.
§ 12-5. Pharmacies manufactured drugs and drugs not dispensed in original packaging when it extradited pharmacy manufactured medicines1 and drugs in other packaging than the manufacturer's original, the following shall be applied medicinal packaging:
A)
drug name;
B)
drug strength;
C)
package size;
D)
drug manufacturer;
E)
manufacturer's production number;
F)
marketing authorization holder;
G)
full declaration in accordance with the original labeling. Such declaration may still be omitted if drug name is unambiguous;
H)
control number, if the product is manufactured in the pharmacy;
I)
expiration date.
Originally expiration date can only be transferred if they have assurance that the same durability comes in new packaging. The original expiration date must always exist in the package documentation.
Prescription medicines will generally also be applied to the usage or directions for use and the pharmacy's name.
A copy of the leaflet should be annexed, if present in the original packaging.
Additional labeling according to §§ 12-6 - 12-9 and other necessary information to ensure proper use shall be applied, unless the provision in § 12-4 first paragraph applies. Such information may be enclosed seal on ordination card / recipe card.
§ 12-6. Additional labeling for use If there is evident from other markings shall:
A)
liquid medicines for use on the skin marked "For use on skin";
B)
suppositories marked "introduced into the rectum";
C)
pessaries marked "introduced into the vagina";
D)
eardrops labeled "drip ears";
E)
infusjonskonsentrater marked "Must be diluted before use";
F)
veterinary medicines labeled "Medicines for pets."
If shorter durability is not specified, the sterile pharmaceuticals labeled with life after opening according to Norwegian drug standards (NLS).
Eye drops for glaucoma treatment should be labeled: "Do not stop treatment without consulting a doctor."
All liquid pharmaceuticals where the active substance may spread unevenly, shall be labeled "Shake before use".
For all injeksjonspreparater1 shall administration stated.
§ 12-7. Additional Labeling Warnings If there already is evident from the standard markings, the following warnings applied medicine before dispensing:
A)
All medicines should be marked "Keep away from children."
B)
Medicines that may impair the ability to cause a motor vehicle or perform hazardous work, oral drugs with ethanol content above 10 percent by weight and other drugs by the Norwegian Medicines Agency provision shall be marked with a warning triangle. Warning triangle design determined by the Norwegian Medicines Agency. If your prescriber indicates on the prescription that a drug may impair the ability to cause a motor vehicle or perform hazardous work, the product should be labeled with a warning triangle.
C)
If the prescription veterinary surgeon stated tilbakeholdelsestid1 for eggs, milk, honey or slaughter, the withdrawal period applied medicine.
D)
If the prescription of veterinary specified deadline to start the competition, shall start deadline applied medicine.
E)
Corrosive substances to be used as drugs to be labeled "Corrosive".
F)
Flammable and explosive drugs should be labeled in accordance with regulations on flammable goods and explosive goods2.
G)
Pharmacies manufactured medicaments containing sodium bicarbonate, which is dispensed without a prescription, must bear the following warning: "The product contains sodium bicarbonate (baking soda). For some, this could be harmful, especially for prolonged use or when the product is taken in higher than recommended doses. "
H)
Drugs with vismutinnhold leading to intake of 1 g or more bismuth salt per day, which is dispensed without a prescription shall be inserted the following text: "This preparation should not be used continuously over a longer period. Persist plagues more than 3 weeks, should they seek medical advice. "
§ 12-8. Drugs without authorization drugs without authorization which is not exempted from the authorization, shall be marked with the following text: "Preparation for approval exemption. This preparation is not generally available in Norway. (Obtained by special application.) "
§ 12-9. Additional labeling of homeopathic preparations, herbs, etc. Homeopathic and anthroposophic preparations, herbs and herbal mixtures and other similar drugs dispensed without a prescription shall be inserted the following text: "The medical effect of this preparation are not rated"
Norwegian Medicines Agency may grant exemptions from this provision or impose any other labeling for certain such preparations.
Chap. 13. Entry into force. Specific provisions
§ 13-1. Entry into force This regulation comes into force on 1 July 1998.
From the same date, the Regulations on 11 November 1993 no. 1021 relating to the requisition and delivery of medicines from pharmacies.
§ 13-2. Use of drugs requisitioned by § 2-10 Eye drops can be obtained pursuant to § 2-10, shall not be used to diagnose patients below the age of 5 years.
§ 13-3. (Repealed)
§ 13-4. (Repealed)
§ 13-5. (Repealed)
Annex I (Repealed)
Appendix II. Changing List
Annex II, the substitution list, not reproduced here, but an updated list see Medicines Agency's website http://www.legemiddelverket.no.
Appendix III: List of drugs in prescription group A and B as fish health biologists may requisition
(Tom until further notice.)
