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Regulations On The Pharmacy (Pharmacy Regulation)

Original Language Title: Forskrift om apotek (apotekforskriften)

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Regulations on the pharmacy (Pharmacy Regulation) date FOR-2001-02-26-178 Ministry Ministry of health and human services published in 2001 booklet 2 entry into force 01.03.2001, 01.01.2002 last edited by-2015-12-17-1708 from 01.01.2016 Change applies to Norway Pursuant LAW-2000-06-02-39-section 1-2, LAW-2000-06-02-39-section 1-6, LAW-2000-06-02-39-section 2-2, LAW-2000-06-02-39-section 2-14, LAW-2000-06-02-39-section 3-11, LAW-2000-06-02-39-section 4-3, LAW-2000-06-02-39-section 5-1, LAW-2000-06-02-39-section 5-2, LAW-2000-06-02-39-section 5-3, LAW-2000-06-02-39-section 5-4, LAW-2000-06-02-39-section 5-5, LAW-2000-06-02-39-section 5-6, LAW-2000-06-02-39-section 6-1, LAW-2000-06-02-39-section 6-3, LAW-2000-06-02-39-section 6-10, LAW-2000-06-02-39-section 6-12, LAW-2000-06-02-39-section 9-2 Announced 09.03.2001 short title Pharmacies regulation Chapter overview : Chapter 1. General provisions (§§ 1-2) Chapter 2. Pharmacy licence (sections 3-13) Chapter 3. A licence for the operation of pharmacies (sections 14-19) Chapter 4. Requirements for pharmacy business (§ § 20-37) Chapter 5. Sales and marketing (§ § 38-50) Chapter 6. Medicine outlets (§ § 51-62) Chapter 7. Entry into force (section 63) legal authority: established by the Ministry of health and social (now health and Human Services Department) 26. February 2001 under the legal authority of the law of 2. June 2000 Nr. 39 about pharmacies section 1-2 fourth paragraph, section 1-6, third paragraph, section 2-2 second paragraph, section 2-14, section 3-11, § 4-3 third paragraph, section 5-1, third paragraph, section 5-2 second paragraph, section 5-3 the second paragraph, section 5-4 first and fourth paragraph, section 5-5, third paragraph, section 5-6 second paragraph, section 6-1 first, second and third paragraph, section 6-3, section 6-10 second paragraph, section 6-12 the third paragraph and section 9-2.
Changes: modified by regulations 21 March 2002 No. 338, 10 June 2003 No. 690, 3 feb 2005 Nr. 92, 12 November 2009 No. 1367, 17 jan 2013 No. 61, 14 Feb. 2013 No. 199, 20 aug 2013 No. 1037, 22 June 2015 Nr. 747, 16 des 2015 Nr. 1687, 17 des 2015 Nr. 1708. Chapter 1. General provisions § 1. (Repealed) section 2. (Repealed)

Chapter 2. Pharmacy licence section 3. The scope of Pharmacy konsesjonens Pharmacy licence should normally be granted with effect for a specific municipality. If the chemist's natural customer base suggests it, pharmacies is given with concession effect for other geographical area than the municipality.

§ 4. The application's content application for pharmacy licence shall include: a) a description of what the pharmacy licence shall include, including any medicine outlets and supplier of permissions. By the acquisition of an already existing pharmacies, it must in addition be informed about the existing pharmacies konsesjonens scope, b) a description of the applicant, accompanied by a separate declaration that he or she is not cut off from owning pharmacies by law or regulation, as well as an overview of the applicant's ownership interests in other pharmacies and other drug companies, c) information about the municipality in which the pharmacy is located or plan created , d) documentation of financial ability, as mentioned in section 5, and e) documentation of academic activities as mentioned in section 6.

Pharmacy licence may be granted on terms that the documentation mentioned in the first paragraph the letters d and e be submitted to the State's drug works within a specified time.
The information is provided in the form laid down by the State's pharmaceutical plant.

§ 5. Evidence of financial ability to operate professionally prudent Concession the applicant should enclose the application a funding plan and a preliminary operating budget for the pharmacy.
When the applicant has not documented a sufficient financial ability to operate professionally prudent, and special reasons for it, the concession application is declined.

section 6. Documentation of assumptions for professional business Concession the applicant should enclose the application a list of: a) the pharmacy's expected customer base, b) the pharmacy's staffing distributed on personal categories, c) existing or planned collaboration with other pharmacies, and d) expected annual turnover divided on drugs, medical equipment, other goods and services.

When the applicant has not documented a probability that the chemist's professional business get a scope that is large enough that the pharmacy's competence as subjects trading and supplier of drugs to be secured and kept by the same, and special reasons for it, the concession application is declined.

§ 7 - § 9. (Repealed by regulation 12 nov 2009 Nr. 1367, in effect 1 jan 2010).

§ 10. Close associates like someone's close associates is meant in the Act: a) spouse and a person that he or she lives with in the ekteskapsliknende ratio, and b) relatives in straight up rising or descent line and siblings.

section 11. Alternative fulfillment of criteria for pharmacies can approve the concession that the Ministry of a criteria for pharmacies offer of concession is met through financial compensation to other pharmacies in the area that are imposed on the same criteria. Pharmacies in the area konsesjonærene the contracting kompensasjonens size. If the pharmacy konsesjonærene cannot agree, the State's drug works fix the compensation at the discretion.

§ 12. Application fee Search of Pharmacy license to the newly created pharmacies must pay a fee of 40,000 dollars. The fee accrue to the Treasury. The fee will be refunded for applicants who have been rejected on the concession application due to establishment ceilings after the pharmacies Act 2-2, third paragraph. The fee may also be refunded in whole or in part in other cases where the establishment of pharmacies not be completed for reasons that cannot be loaded is seeking. For applications for pharmacy licence for to fulfill the obligations under the agreement with the Government to secure pharmacy coverage in rural areas, are paid there is no application fee.

section 13. Konkurransepolitiske into account cannot be granted concession Pharmacy if the consideration of a functioning competition in the pharmacies market suggests it and the applicant: a) owner or organizes pharmacy that overall has a turnover that make up more than 40 percent of the total turnover in the country's pharmacies that are not hospital pharmacies, or b) has a significant collaboration with enterprises as mentioned in the letter a.

The first paragraph is not, however, preclude that the pharmacy licence can granted if the consideration of a proper drug supply makes it necessary.

Chapter 3. A licence for the operation of pharmacies section 14. Application for operating licence application for the operating concession embodied in the form laid down by the State's drug works and be signed by the applicant.
Together with the application for the operating licence to the applicant enclose information from pharmacies konsesjonæren that will make that the pharmacy filling the requirements that apply to the pharmacy business, and that shows how the individual requirements are met or intended met. The information to be given in the form laid down by the State's drug works, and signed by pharmacies konsesjonæren.
Operating licence can only be provided if the chemist's premises are approved by the licensing authority.
The operating licence may be granted on terms that the documentation for the fulfillment of one or more of the requirements of the law be submitted to the State's drug works within a specified time.

section 15. Apothecary's presence in the pharmacy the pharmacist should be present in the Pharmacy and in the corresponding branch pharmacies to an extent that ensures that he or she attends their functions as General Manager. The pharmacist should at least be present at a time corresponding to half position.
The pharmacist should carry out a substantial portion of its leader tasks in the chemist's premises, or in premises designed for this in the pharmacy's immediate vicinity.

section 16. Substitutes When the pharmacist is not present in the pharmacy, the pharmacy's daily operations are left to a person among the pharmacy's pharmaceutical staff, cf. pharmacies Act § 4-1. Backup should have the necessary powers to attend to their duties. The pharmacist shall ensure that all staff are informed about who is at all times seems like the Deputy.

§ 17. Ineptitude an applicant is considered unfit to hold the operating licence if the special relationship implies that this person will not be suitable to operate the pharmacy in accordance with the law or pharmacy professional claims.
As unfit to hold the operating licence is considered always a person who in the course of the last five years: a) is convicted of an economic crime with penalties of up to 3 years or more, b) have or have had a serious substance abuse problem, or c) has lost its operating licence because of reckless personal exercise of the rights and responsibilities that pharmacy.

§ 18. Police certificate applying to operating concession must by law enforcement certificate documenting the Honorable record. Foreign nationals who are applying for a pharmacy licence, be exempted from the requirement if such certificate can be issued not by the Norwegian or foreign law enforcement authorities.

§ 19. Approval of facilities Essential renovations or ominnredninger of the pharmacy shall be approved by the State's pharmaceutical plant.

Chapter 4. Requirements for pharmacies the business section 20. (Repealed) § 21. Requirements for the premises shall have the Pharmacy showroom a design that clearly delimits the pharmacy from the surrounding space. The pharmacy shall not be construed as a part or natural extension of other corporate offices. Access to the pharmacy's public's zone to attend the motion-and orienteringshemmedes universal access. The public should have sufficient opportunity to be able to sit in or in the immediate vicinity of the public's room.
The premises shall be secured against burglary.

§ 22. (Repealed by regulation 12 nov 2009 Nr. 1367, in effect 1 jan 2010).

§ 23. Storage of drugs, etc. Drugs in the prescription Group A and B, and similar drugs without marketing authorization, should be kept in FG-approved security cabinet in the time the pharmacy is not manned. This requirement can be waived, if the pharmacist can substantiate similar security measures. Drugs in the prescription Group A should always keep locked up.
Drugs prepared for disclosure are exempt the requirement in the first paragraph as far as it is considered prudent.
Not marketable items should keep away from items intended for sale.

section 24. (Revoked 1 jan 2010 by regulation 12 nov 2009 Nr. 1367.)

§ 25. The chemist's opening hours with the opening time refers to the time the pharmacy is open for the expedition and the provision of goods to negotiation the audience obliged.
The chemist's opening hours shall be reported to the State's drug works. The local health and Human Services service and the public should appropriately be informed about the opening hours, including short term closure of the pharmacy.

§ 26. The pharmacy's bargaining duty Pharmacy has the duty to negotiate: a) all drugs that are approved for sale in Norway b) drugs that must be produced for the individual after the prescription and which is requested by a physician, dentist, or veterinarian) recommended c drugs by other health care professionals in the health and Human Services service, except medicines are can be harmful, or obviously inappropriate in use d) common medical equipment used by consumers , or that is necessary to achieve the proper use of drugs. The duty also applies to medical devices that are not in common use, but which are important for specific patient groups. The obligation applies under the condition that such equipment is available to pharmacies in Norway e) food and skin care agents that may be required in the medical treatment of humans.

§ 27. Item deliveries between pharmacies Pharmacies with common operating licence can deliver drugs to each other regardless of demands for wholesaler permit.
Pharmacies with the same pharmacies the concessionaire can deliver drugs to each other in cases a) where it imposes an unreasonable inconvenience for the customer to pick up the medication at a different pharmacy b) that apply to drugs that are stored for emergency purposes and which will be able to go out on a date and had to be scrapped if the medicines are not available to other pharmacies c) that apply to drugs that are redundant because of the relocation of the specialty/function between hospital d) that apply to drugs that pharmacies have ordered to a particular customer but still not where the customer buys the medication e) relating to the acquisition of pharmacies including drug store and pharmacy to continue where progress in the same premises.

The State's drug works in other particular cases give permission to pharmacies deliver drugs to another pharmacy of the same pharmacies the concessionaire.
Item delivery according to the second paragraph shall be documented by the utterly honest pharmacies. The documentation should include the date of delivery, the recipient, the carrier, transport mode, which drugs that are delivered and the reason for that the shipment meets the criteria in the second paragraph. For deliveries in accordance with the letter a to d shall be specified in the batch number on the drugs delivered. Documentation should be kept for five years.
Pharmacies that deliver the drug to other pharmacies are responsible for that message about the recall of the drug imparted to the pharmacies they have delivered the drug.
Deliveries that are not covered by its provision requires wholesaler permit.

section 27a. The obligation to stock medicines if the pharmacies stocks a drug that is on the Exchange list, but not included in the step pricing system, the duties of the pharmacy to stock the cheapest preparation in Exchange group with smaller price difference is negligible.

section 28. Posting Requirements For pharmacy accounting and financial statements shall apply the same rules as apply at any time according to the fiscal legislation. The exception from the fiscal obligation arising out of the accounting Act § 1-2 will not apply to pharmacies.
In addition to the rules in the first paragraph shall be set up Pharmacy and financial statements in accordance with a chart of accounts for pharmacies established by the State's pharmaceutical plant.

section 29. Audit, assurance and submission of accounting Pharmacies konsesjonæren shall ensure that the financial statements be revised and attesteres by at least one registered auditor or a chartered accountant and Auditor legislation followed. The State's drug works can agree that others with similar skills audits and financial statements attests. The exception to the duty of the audit provided the Auditor Act 2-1, will not apply to pharmacies.
Each year, within two months after the fiscal year-end, to pharmacies fill out konsesjonæren and submit to the State's drug plant extracts of Pharmacy accounting on the fixed forms. Pharmacies the concessionaire that waive pharmacies during the year, the concession, shall submit the statement within three months after the pharmacy licence has fallen away.

section 30. Control with drugs Pharmacy shall have the necessary control of prescription drugs in the Group A and B and similar drugs without marketing authorization, which is kept in the pharmacy. It should be a regular control of the theoretical and actual quantities on hand to comply. Any discrepancies should be clarified as far as possible, and measures should be taken to prevent further disputes. Documentation of completed control as well as any actions taken should be kept for at least five years.

section 31. To register the drug Pharmacy purchase accounting, disclosure, scrap by manufacture, loss by games, breakages and kassasjon of medicines in a prescription Group A and all other drugs where there are included substances listed on the drug list under conventions N1 and P2. The State's pharmaceutical plant can make exceptions for specific substances, drugs or preparations and also decide that the registration and accounting obligation in whole or in part, should be made applicable to other substances, drugs or preparations which can be easily misused.

section 32. Storage of drugs accounting Drug accounting with vouchers should be kept in the pharmacy for at least five years.

section 33. Message about the loss of the drug loss of medicines in a prescription Group A or B and similar drugs without marketing authorization, which occurs by theft, withdrawals under false pretenses from the chemist's staff or other unforeseen reasons, shall be reported to the State's drug works. The same applies to essential balance differences, when the cause of the anomaly is not found.

section 34. Definition of internal control and internal control deviation is meant in this regulation which will ensure the systematic measures that the pharmacy's activities be planned, organized, carried out and maintained in accordance with the requirements that target pharmacy in or in pursuance of pharmacies and health laws.
With the discrepancy meant lack of fulfilment of the requirements set out in or pursuant to the law or regulations.

section 35. The duty of the internal control Pharmacies is responsible for all pharmacies that he or she has responsibility for, has a system of internal control that meets the requirements of this regulation.

section 36. The contents of the internal control Internal control should be adapted to the pharmacy's size, distinctive character, activities and conditions that can result in the risk of the pharmacy's customers and business partners, and have the scope that is necessary to comply with the requirements set out in or pursuant to the drug, pharmacies and health legislation.
Internal control requirement means that those responsible for the business to be a) describe the pharmacy's main tasks and goals, including quality objectives and other goals for improvement work, as well as how the business is organized so that it is clearly stated how the responsibilities, tasks and authority are divided, including the cooperative relationship b) ensure access to relevant laws, regulations and professional standards of good pharmacy or manufacturing practices that apply to the pharmacy's business c) establish practices that safeguards the client's/patient's security and ensures that the current standards and regulations are observed d) make sure that the everyone who works in the pharmacy, have sufficient knowledge and skills within the appropriate subject field, as well as about the enterprise internal control e) make sure that the employees contribute so that the collected knowledge and experience be exploited f) make use of the experiences of clients/patients and other partners to the improvement of the business, as well as take action to correct and prevent deviations and complaints g) provide overview of the areas of the business where there is a risk of failure or lack of fulfillment of government requirements make sure h) regular review of internal control to ensure that it works as intended and contribute to the continuous improvement of your business.

section 37. Documentation the pharmacy will be documenting that the business is run in accordance with the then-current rules of the business, including the requirements set as criteria to pharmacies and the operating concession.
Internal control shall be documented in writing to the extent that is necessary to ensure a) that the management and the employees of the Pharmacy has knowledge of the pharmacy's internal control b) equal to the understanding and implementation of internal control system in the pharmacy c) control of the pharmacy's internal control activities, the results of them and carried out improvement measures.

The most central tasks in the Pharmacy and work tasks that have great importance for the customer's security, to pharmacy always be documented in writing.
The pharmacy shall have a system for document management, which ensures that the necessary internal control documents at any time is up to date and available.

Chapter 5. Sales and marketing section 38. (Repealed by regulation 12 nov 2009 Nr. 1367, in effect 1 jan 2010).

§ 39. Hospital delivery apoteks right individual decisions after the pharmacies Act 6-1, third paragraph, that a hospital delivery for apoteks right negotiation obliged lasts only to apply to the cooperative hospital as well as the hospital's employees and users, can get hit by the State's drug works if: a) hospital pharmacy receives services from a hospital without providing full consideration, and b) these services are suited to give hospital pharmacist a particularly favourable position in relation to other pharmacies in the same municipality or area.

section 40. Service provision in the pharmacy a person with the right to commandeer the drugs can only provide organized health care in the pharmacy if he or she has education as mentioned in the Pharmacy Law § 4-1, the first paragraph. This is not, however, preclude that person with the right to commandeer the drugs can provide product neutral health information in the pharmacy.

section 40a. Cooperation with wholesale Pharmacy duties in a reasonable extent to assist their suppliers in the quality assurance of shipment of goods between supplier and pharmacies.

section 40b. Drugs for kassasjon the pharmacy shall have routines and any agreements with external actors to ensure that drugs for the kassasjon will be disposed of in a proper manner. Drugs should as a rule be destroyed by incineration.

§ 41. Drug shipment with shipment is meant in this Regulation any distribution of drugs outside the pharmacy's operating facilities.
Before a new shipping method is applied, to ensure that the pharmacist the requirements in the regulations on medicines from the pharmacy Chapter 11 are taken care of. The pharmacy shall be by random sampling or in some other suitable way quality ensure their shipments.
When shipping to the pharmacy to ensure traceability to ensure proper disclosure and drug management.

§ 42. The sale of drugs over the Internet with the sale of drugs over the Internet is meant in these regulations the sale of drugs when the agreement is conveyed electronically and be entered into without the customer is physically present in the pharmacy.
Pharmacies that sell drugs over the Internet, is obliged to give the State's pharmaceutical plant up-to-date information about the following: a) the address of the place that medicines are to be extradited from, b) the time when the sale of drugs over the Internet begins, and c) the address of the site to be used and any other relevant information necessary to be able to identify the site.

[Site should contain the following: a) a logo, set by the State's pharmaceutical plant, on every page of the site, that identifies where the seller of the medicines is established, b) a link to the State's drug network information page on the Internet about the sale of drugs over the Internet, and c) a link from logo as mentioned in the letter a), to the State's drug network electronic list of actors who have permission to sell drugs over the Internet.]

By the sale of prescription drugs over the Internet to pharmacies offer all drugs allowed sold in Norway, cf. Pharmacy Law § 5-3. The pharmacy can fail the shipment of drugs with special requirements for the consignment, storage or durability, and medicines that require particular care by disclosure. Information about delivery time, price, and which drugs, if any, not be sent, should arise on the site.
The sale of prescription drugs over the Internet won't happen to people under 18.
Pharmacies to disclose how the customer can get in touch with pharmacies personnel, and obtain contact information about the customer.
By the sale of prescription drugs over the Internet, the client should authenticate before lookup in prescription provider. Data treatment responsible for prescription provider can establish guidelines for such authentication.
By the sale of drugs over the Internet to the website be designed so that confidential information is not shared with third parties through the use of cookies or similar, except when this happens within the framework of a databehandleravtale and in accordance with the rules on confidentiality.
The third paragraph goes into effect when the Ministry determines the jf. Regulation 20 aug 2013 No. 1037 Roman numeral IV last paragraph.

section 43. Shipment to the output place Pharmacies that make use of a particular output place for drugs provided by shipment, must ensure that the routines used on output rather than ensuring proper storage and dispensing of drugs.

§ 44. Shipping refund expenses for shipping as stated in section 41 of the drugs prescribed by a doctor or dentist, pharmacy only get reimbursed when the shipment tilsies of geographical conditions, the consumer's physical or mental health condition or other circumstances that make extradition in pharmacies to a particular strain for the consumer.
The State's drug works sets out closer to guidelines on shipping refund.

§ 45. Exposure and availability of drugs Drugs that can only be divulged to the prescription shall not be placed in the even-selection Department. Other drugs can be placed in even the extent selection Department in lokalets design, and the pharmacy's routines ensures a professional proper disclosure of the medicines, including that: a) the provisions on restrictions on the provision of drugs without a prescription is met, b) the pharmacy's personnel at any given time can easily monitor the drugs that could be abused or for any other reason should be a particular oversight of, c) the customer has good access to the necessary information and personal guidance of qualified staff on the use of the products , and d) even choice is designed so that Department the customer receives an overview of a reasonable range of medicines that can cover the same therapeutic needs, including current drugs that are not in themselves the election.

The State's drug works can still decide that certain drugs or drug groups should not be placed in even the election.
The sale of drugs from the vending machines and similar devices is not allowed.

section 46. Medical information Pharmacies to make sure that medical information that the pharmacy makes available to the public, be drawn up in accordance with the current rules on the advertising of drugs.
Medical information the pharmacy makes available to the public and not covered by the regulation on advertising for drugs, to have a proper and reliable content.
It should clearly be stated who has prepared the medical information.

§ 47. Addressed advertising, etc., the pharmacy can only send advertising directed at the individual customer's specific drug use or disease state if the customer has given an informed and written consent to be contacted with this purpose. The individual customer can at any time withdraw the consent back orally or in writing.

section 48. Reminder advertising the use of reminder advertising (reminders) for drugs are not allowed in that part of the pharmacy that is visible to the general public or in any other outward looking marketing to the general public.

section 49. Marketing of prices and discounts Pharmacy can not represent the prices and discounts in their marketing in a way that can promote random purchases of medicines.

§ 50. The relationship to the rekvirenter the pharmacy may not enter into an agreement with the person with the right to commandeer the drugs: a) obviously will be able to reduce the patient's ability to choose even pharmacies, or b) associate forskriverens discount or earnings to the value or the quantity of the requisitions or prescriptions that the pharmacy receives.

Chapter 6. Medicine outlets § 51. The creation and transfer of medicine outlets the creation of medicine outlets shall be made according to the provisions of the Pharmacy Law § 2-7 second paragraph letter a or section 2-8 first paragraph, LITRA e. transfer of responsibility for a medicine outlets to another pharmacy shall comply with the rules on the waiver and the creation of medicine outlets.

§ 52. Forgo the medicine retail outlets Pharmacies konsesjonæren can give up their right to operate medicine retail outlets. Written notice of the waiver is to be sent to the State's drug works.

section 53. (Repealed by regulation 12 nov 2009 Nr. 1367, in effect 1 jan 2010).

§ 54. Medicine utsalgets premises and inventory facilities and fixtures to ensure proper storage of drugs and other goods. Medicine utsalgets to be used for inventory only storage of the goods received from the pharmacy.
Medicine outlets shall be provided with a clearly visible exterior signs where it clearly appears that the venue can accommodate a medicine outlets and which pharmacies that have the responsibility for the operation.

section 55. Storage of drugs Drugs and other items to be kept safe.
Drugs with special requirements for storage should be kept under the conditions imposed by the requirements of the individual product. Not marketable drugs should be kept separate from the other items and immediately returned to the pharmacy.

section 56. The provision of medicines from medicine outlets Extradition of drugs should take place according to the written directions given by the pharmacy. The guidelines are to ensure proper disclosure, jf. Pharmacy Law § 6-7, and be known by all who dispenses drugs in medicine outlet. Drugs should, with the exceptions established by the State's drug works, always are available of the medicine utsalgets staff.
The drug does not have to be disclosed when it is assessed as likely that it will be abused.
Drug from the medicine outlets shall not be disclosed to the person under 18 years of age.
Items will be shipped in the same State customers and gasket as they are received from the pharmacy. In the medicine retail outlets must not be made any backfilling, overfilling, sharing or similar treatment of the goods.

§ 57. Drugs etc. that can be sold in the medicine retail outlets From medicine outlets can only be sold prescription drugs, medicines exempt from prescription and other goods duty that can be sold from pharmacies without special requisition. It must not be sold other drugs than those who receive the outlet from the pharmacy.
The State's drug works can exempt from selling certain drugs or other items that can be misused or who for other reasons should not be allowed sold from medicine outlets. It can also be determined which drugs and medical equipment medicine outlets always should be provided with.

section 58. Of contents of item selection the pharmacist shall in consultation with the municipality the doctor prepare and maintain list of the items that should be entered in the medicine outlet. The list should include those drugs that are necessary in order to safeguard the population's need for common drugs for their own care.
The pharmacist should revise the list as necessary and at least once annually. The municipality of doctor to have copy of the lists from time to time with special setting changes on the list.

section 59. Marking of goods other items that drugs and medicine outlet receive from the pharmacy, shall be inflicted on the pharmacy's name, and as far as possible the usage guide and information about the application.

section 60. The relationship between the Pharmacy and medicine outlets items that are intended for sale in medicine outlets, should be the chemist's property. The pharmacist determines the retail price of the goods.
It may not be exercised tilbakeholdsrett in the chemist's medicines.

section 61. Management of medicine retail outlets to the outlet of the Medicine bestyres a person who is approved by the pharmacist. Pharmacies konsesjonæren shall enter into a written agreement with the manager about its rights and obligations, including of any competence to delegate authority.

section 62. Responsibilities and supervision is responsible for the pharmacist a) items sold in the store of medicine, satisfactory quality b) the operation of the medicine store is proper and in accordance with regulatory disclosure of c) pharmaceuticals and other goods in medicine the store happens according to the guidelines that are given by the pharmacy there is a d) plan for academic follow up of medicine outlet.

The pharmacist or person empowered by this, to lead the necessary supervision of medicine the store at least once every year. Supervision shall be documented.

Chapter 7. Entry into force § 63. Entry into force these regulations shall enter into force 1. March 2001, with the exception of section 20 which takes effect 1. January 2002.