Read the untranslated law here: https://lovdata.no/dokument/NL/lov/2000-06-02-39
The law on pharmacy (pharmacy Act).
Date LAW-2000-06-02-39 Ministry the Ministry of health and care services last modified the law-2015-06-19-59 from 01.07.2015, law-2015-06-19-65 from 01.10.2015 Published in 2000 booklet 12 entry into force 01.03.2001, 01.07.2001 (section 8-1) changes Announced short title Pharmacy Law-apotl.
Chapter overview: Kap. 1. General provisions (§ § 1-1-1-6) Chapter. 2. Concession to the ownership of pharmacies (§ § 2-1-2-14) Chapter. 3. Concession for the operation of pharmacies (§ § 3-1-3-11) Chapter. 4. The chemist's staff (§ § 4-1-4-6) Chapter. 5. Basic requirements for pharmacy business (§ § 5-1-5-8) Chapter. 6. Sales and marketing from the pharmacy (§ § 6-1-6-12) Chapter. 7. Production of medicines in pharmacies (§ § 7-1-7-3), Chap. 8. Supervision of pharmacies (§ § 8-1-8-5) Chap. 9. Administrative provisions and punishment (§ § 9-1-9-5) Chap. 10. Entry into force. The transitional rules (sections 10-1-10-5) cf. the law 4 des 1992 Nr. 132 (drugs). -CF. the previous regulation 4 des 1672, 6 feb 1686, 21 apr 1812, laws 25 feb 1860, June 6, 1877 Nr. 2, 4 aug 1909 (additional laws 20 aug 1915 No. 4, June 29, 1917, no. 1, 28 July 1921 No. 5, 23 May 1930 No. 6, 17 June 1932 No. 1, regulation 12 Oct 1940, laws June 13, 1947, no. 1, 15 des 1950 No. 9, 27 Feb. 1953, no. 2, May 31, 1963, no. 2), July 25, 1910 Nr. 2 (additional law June 7, 1913), 8 March 1935 kap. 9, 21 June 1963 No. 17. Chap. 1. General provisions § 1-1. Purpose this law have to purpose to ensure proper disclosure of pharmaceutical products to the end user. The participants to the appropriate drug use in the population and to good availability in all parts of the country to the drugs and pharmaceutical services that have good quality and reasonable price.
§ 1-2. The scope of the law apply to pharmacies.
The armed forces ' pharmacies will not enter under this law, unless otherwise determined by the King. The King can give the regulations on their business.
The King may decide that certain pharmacies owned and operated by the State shall be exempted from certain provisions of this law.
The King provides regulations on the application of the law on Svalbard and can establish special rules under consideration for the on-site conditions.
§ 1-3. Definitions in this law is meant by: a) pharmacies: POS for medicines to the end user where there is drug professional guidance, which is physically available to the public;
b) hovedapotek: the pharmacies where the pharmacist has the on-site management when operating the concession also includes the branch pharmacies;
c) branch pharmacies: pharmacies under the same pharmacy licence and operating licence as a hovedapotek;
d) hospital pharmacies: pharmacies in collocation with the public hospital or private hospital that is part of public health programs, as have drug supply to the hospital as their primary task;
e) medicine outlets: separate the output place for drugs that are subject to a specific pharmacy;
f) pharmacies: person with operating concession to pharmacies pursuant to section 3-2;
g) drug: drugs, drugs or preparations mentioned in the medicines Act § 2 subsection cf.. regulations given in pursuance of the medicines Act section 2 the second paragraph;
h) manufacture: manufacturing, packaging, repackaging, labelling, ometikettering and release of drugs as well as the necessary controls in connection with these activities;
in) prescription: rekvirering of medicines to use for specific people or animals from the person with rekvirerings right;
j) requisition: rekvirering of drugs from the person with rekvirerings right otherwise than by prescription;
k) expedition: pharmaceutical control and istandgjøring of the drug according to a prescription or requisition.
section 1-4. Demands for concession to own and operate pharmacies required public approval in the form of concession to ownership to the pharmacy after kap. 2 (pharmacy concession) and the concession for the operation of the pharmacy for kap. 3 (operating licence).
section 1-5. The use of characteristics to outwardly signify Pharmacy themselves with the word pharmacy. Hospital pharmacies can denote them outwardly as hospital pharmacies. The pharmacy's own name shall be approved by the Ministry, that can deny the special name used.
The word Pharmacy and compounds that contain this word, not used as a designation for any business that is not Government-approved pharmacies by law. Such words must not be used as the designation of and advertising for products not covered by the pharmacy bargaining obligation.
The title pharmacies must not be used by someone who is not pharmacy under this Act. Commercial use of the word compounds containing this title, is not allowed.
section 1-6. Liability For the patient's injuries comes to rules of patient injury law.
Pharmacy liability by the manufacture of drugs is regulated in the product liability Act Chapter 3.
For General replacement rules.
Kap. 2. Concession to ownership to the pharmacies section 2-1. The concession authority Concession to ownership of the pharmacy (pharmacy licence) granted by the Ministry.
section 2-2. Pharmacy licence with the limitations imposed by section 2-3, an applicant the right to the pharmacy licence if the following requirements are met: a) the applicant must document the financial ability to operate professionally prudent, in accordance with the requirements set out in the business to pharmacies law and regulations, including the financial ability to offer necessary ikkelønnsomme pharmaceutical services.
b) applicant must document the 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. The claim can be documented in the community with other or other nearby pharmacies with the same owner, or in committed relationship.
The Ministry may by regulation fix the rules that limit the right to a licence under this section if the konkurransepolitiske into account requires. The Ministry may by regulation fix the rules that limit the right to a licence under this section if the consideration of a geographic proper distribution of pharmaceutical personnel requires. Such rules may not limit the right of the transferee's pharmacy licence by the acquisition of an existing pharmacy and the owner's right to the new concession for existing pharmacies by the conversion of eierform.
§ 2-3. Applicants who can not be given concession after concession pharmacy Pharmacy section 2-2 can not be granted if: a) the applicant has the right rekvirerings for drugs, industrial supplier of drugs or is affiliated with such supplier or company who takes ill in treatment. The same applies if the applicant has such close, unless the Ministry make exceptions in each case.
b) seeks is a company that takes sick in treatment or an industrial enterprise as supplier of drugs. The same applies if the applicant is a company that is headed by the person with the right rekvirerings for drugs. Unless the Ministry make exceptions in each case, the requirement applies to the company's General Manager, the members of the Board of Directors and their close associates, as well as all company participants and their close associates if the entity is a responsible company.
c) seeks is a company that directly or indirectly owned by 10 percent or more of the person with the right rekvirerings for drugs or by close associates to this or of undertakings that take sick in treatment or of the undertaking which has control of such undertaking. The limit also applies to cooperative groups of such persons. The Ministry may in each case make exceptions from the border in the first sentence for related to person with rekvirerings right.
d) seeks is controlled by one or more industrial manufacturers of medicinal products or of undertakings which directly or indirectly owns 10 per cent or more of such manufacturers.
e) seeks is in control of a company that takes sick in treatment.
An entity has control over another undertaking when it takes place before this in an unbroken string of companies that have controlling interest over a blocking minority stake or a third or more of the vote or the share capital in the next entity in the series.
If the applicants have previously had pharmacies concession which is called back under section 2-13, new concession is granted only if the Ministry finds it ubetenkelig. The same applies if the applicant or his representatives or owners with controlling interest, has had a controlling influence over the pharmacies the concessionaire that has lost the license due to the revocation or lapse.
§ 2-4. Pharmacy license to municipalities and county municipalities in particular cases can be given to the pharmacy licence municipalities and county municipalities, and to the enterprise that is owned entirely by a municipality or County Council.
section 2-5. Pharmacy license to hospital pharmacies Pharmacies concession to hospital pharmacies can be given to the State, municipalities, county councils and to enterprises that are owned entirely by the State, municipality or County Council. Concession to the hospital pharmacies may also be given to the private applicant.
Applicants must meet the requirements in section 2-2 CF. § 2-3 first paragraph, LITRA a, b and d.
§ 2-6. (Repealed by law 19 June 2009 No. 71 (ikr. 1 jan 2010 according to. res. June 19, 2009 No. 689).)
section 2-7. Pharmacies konsesjonens scope A pharmacy licence includes a specific pharmacy in a specific geographical area.
Pharmacy license may otherwise include: a) Permission to the creation of medicine outlets in areas without pharmacies. Permission to have medicine outlets can be called back with 6 months notice, and will be called back if it established a pharmacy on site.
b) supplier of permission under section 7-1 and permit pursuant to section 7-3 third paragraph to the sales to pharmacies and wholesaler of medicinal products which are manufactured to the inventory.
section 2-8. Criteria for pharmacy licence it can be set criteria for pharmacies when there is the license required for the sake of the goals the law to promote, including conditions regarding: a. collaboration with the local health and human services the service b. execution of pharmaceutical quality control in the local health and Human Services service c) execution of the health services that are in close relationship with the disclosure and use of drugs d) assurance of the availability of the drugs through the special opening times or function as a guard pharmacies e)
securing the drug supply through the creation and operation of pharmacies or medicine outlets in the area without pharmacies offer, or through the takeover of the pharmacy or medicine shop in the area that are in danger of losing the pharmacies offer f) intervention to the proper drug emergency g) the manufacture and supply of essential drugs for the sake of the national drug supply.
Instead of the naturaloppfyllelse of the terms and conditions as are required by the first paragraph, the Ministry can approve that the criteria are met through the provision of financial compensation to other pharmacies in the area that are imposed on the same criteria.
Terms and conditions as mentioned in the first paragraph can be set even after the license is granted.
section 2-9. Legal effects of Pharmacy license Pharmacies concession means the right and duty to establish and operate pharmacies, medicine outlets and production of drugs, as specified in the license, see. section 2-7 and § 2-8.
The legal effects if the operation of the pharmacy is not started 12 months after the licence is granted and a new closing date is not set.
section 2-10. Disclosure and specific report to give konsesjonæren the duties of the Pharmacy Department Notice of significant changes on the information that is the basis for the concession decision.
section 2-11. The acquisition of pharmacies licensed Pharmacies, etc. may not be assigned licences.
At konsesjonærens death and bankruptcy and by the transfer of Pharmacy falls the concession away. Death or bankruptcy estate may by notification to the Ministry still take over the rights and duties after the pharmacies for a period of the licence up to 6 months. The period can be extended after application.
section 2-12. Waiver of the pharmacy licence Pharmacies konsesjonæren can give up the license and on the permissions given in relation to the concession. By forgoing the concession falls or the permit away 3 weeks after the relinquishment is given, but by decision after the second paragraph, where the lapse occurs first at the end of the phasing-out period.
The Ministry may extend the legal effects for the concession or the permissions for up to 12 months after the konsesjonæren has given up on it. Such a decision must be taken no later than 3 weeks after the relinquishment is given. The Ministry responds to economic loss as the operation has caused konsesjonæren in the phasing-out period.
section 2-13. Revocation and amendment of Pharmacy License Department can revoke the license if the criteria for a pharmacy section 2-2 CF. § 2-3 no longer exists.
Pharmacy license can also be called back: a) by breach of terms and conditions that are set under section 2-8 b) by breach of the reporting duties of Pharmacy konsesjonæren according to law, regulation or decision c) by inadequate intervention under supervision, jf. section 8-2 d) at the closing of the pharmacy pursuant to section 8-5 or by other operating the cessation as the owner responds to s) by waiver of the operating concession, if relinquishment is justified in uforsvarlige framework conditions for operation f) by deficient fulfilment in the pharmacy of the standards of quality and safety arising out of the law, regulation or decision or of good pharmacy or manufacturing practices.
If the callback reason in the first and second paragraph only applies to medicine outlets or the chemist's manufacture of drugs, the callback be limited to apply this section of Pharmacy license.
Pharmacy licence can also be called back if it makes itself the current conditions at pharmacies konsesjonæren that must be assumed to make them unfit to own or exercise eierrådighet in pharmacies. By enforceable judgement of lapse of the right to own pharmacies to the concession is revoked.
section 2-14. Regulations the Ministry may give further provisions to the completion and implementation of the policies in this chapter.
Kap. 3. Concession for the operation of pharmacies section 3-1. The concession authority Concession for the operation of pharmacies (operating licence) granted by the Ministry.
section 3-2. The right to the operating license has the right to Seek operating licence to a specific pharmacy if the following requirements are met: a) the applicant has Norwegian exam cand. pharm., master's in pharmacy or foreign education be recognised as being equivalent with Norwegian exam, jf. helsepersonelloven § 48 a first paragraph, LITRA c.
b) Seeking has at least 2 years of pharmaceutical practice after graduation, of which at least 12 months by pharmacies from the European economic area. Pharmacy practice from countries outside the European economic area can be added to reason if it is considered relevant to Norwegian conditions.
c) Seeking authorization has provisorfarmasøyt.
d) Searches have Honorable record according to police testimony.
e) seeks to be the General Manager of the pharmacy.
f) do not apply to operate unfit pharmacies.
The same person may not have more than one operating licence at the same time. In particular cases it may be allowed, that the same person can maintain an operating licence for up to 6 months after the person has begun to act as pharmacies on the basis of new operating licence.
section 3-3. Requirements for pharmacies the business Before operating the concession is given must prove that pharmacy pharmacy konsesjonæren fills the requirements that apply to the pharmacy business, including that it can be documented satisfactory ability to deliver of Pharmacy-made drugs.
section 3-4. Branch pharmacy in addition to hovedapoteket, permission is granted for the operation of up to three branch pharmacies, each of which should be under the on-site management of a person with authorization as provisorfarmasøyt or reseptarfarmasøyt, if pharmacies will make konsesjonæren that: a) Person with qualifications as mentioned in section 3-2 the first paragraph does not employ that pharmacies of causes that cannot be loaded pharmacies konsesjonæren.
b) Pharmacy pharmacy services that offer population cannot acquire in any other way without unreasonable expense or inconvenience. In special cases, this requirement waived.
The requirements of the first paragraph, LITRA a and b does not apply if the pharmacy on the application time is in operation as the branch pharmacies. In this case, the permission tidsbegrenses to the duration of the employment relationship to the pharmacy's head branch on-site.
§ 3-5. Terms of operating licence It can be set such terms for operating concession which are considered necessary for the pharmacist should be able to exercise their daily management of the pharmacy's business proper. Such terms can be set even after the license is granted.
§ 3-6. The relationship between konsesjonærene the pharmacist will ensure that the business at all times meets the academic requirements for pharmacy business that follows from the law, regulations, decisions and good pharmacies-and manufacturing practices.
The pharmacist shall follow pharmacies guidelines and konsesjonærens orders in their daily management of the pharmacy as far as the academic requirements that apply to the business is not an obstacle for it. If an order or a guideline is in conflict with the academic requirements for the pharmacy, is decided in the case of doubt by the Ministry.
Cases that after your business relationship is of unusual nature or of great importance, the pharmacist shall submit pharmacy konsesjonæren for decision, unless the case can not be delayed without significant inconvenience to the pharmacy or the customer.
Matters of employment, termination, suspension, dismissal and transfer of the pharmacy's staff will be determined always of Pharmacy konsesjonæren after setting from the pharmacist, with less decision-making authority in these matters fully added to the pharmacist.
§ 3-7. Operating the concession charge by apotekers absence By illness, leave of absence and other temporary absence of 1 month should be left to the business management daily a person with the right to exercise the profession as provisorfarmasøyt or with the reseptarfarmasøyt authorization. He or she shall have sufficient practice to take over the pharmacy operational responsibility. By continuous absence over 3 months should be sent message to the Ministry. The period may not normally exceed 12 months, but the Ministry may in particular cases authorize that it be extended.
section 3-8. Takeover of the operating licence, etc. Operating concession may not be assigned.
The concession falls away when apotekers working conditions ends. The rights and duties after the license can by message to the Ministry still be transferred for a period of up to 6 months to another person that fills the criteria in section 3-2, or to a person who fills the requirements to take over operational responsibility under section 3-7.
§ 3-9. Revocation and amendment of operating licence Department can finally or temporarily revoke the operating licence if the requirements to have it pursuant to section 3-2 the first paragraph no longer exists.
The same is true: a) by breach of terms and conditions that are set under section 3-5 b) by breach of the reporting duties of the pharmacist according to the law, regulation or decision c) by inadequate intervention under supervision, jf. section 8-2 d) by reckless personal exercise of the rights and responsibilities that pharmacy.
If the callback reason applies only to branch pharmacies or medicine outlets, the callback will be limited to this part of the operating concession.
section 3-10. At the same time lapse of pharmacies and the operating concession By waiver, recall and lapse of pharmacies the concession falls away while operating the concession pharmacies concession.
section 3-11. Regulations the Ministry may give further provisions to the completion and implementation of the policies in this chapter.
Kap. 4. The chemist's staff section 4-1. The chemist's professional staff chemist's pharmaceutical staff are employees with the right to exercise the profession as provisorfarmasøyt or reseptarfarmasøyt.
The pharmacy's technical staff are the employees with the right to exercise the profession as pharmacy technicians.
§ 4-2. (Repealed by law 19 June 2009 No. 71 (ikr. 1 jan 2010 according to. res. June 19, 2009 No. 689).)
section 4-3. Human resources requirements are to have a Pharmacy academic staff in number and expertise are sufficient to ensure good quality and safety by the pharmacy's storage, manufacture, expedition and the provision of medicines. Pharmacy konsesjonæren to contribute to the necessary further-and continuing education.
At least one person accompanying the pharmacy's pharmaceutical staff should be present in all the opening hours.
The Ministry may by regulation provide further provisions on human resources requirements in the pharmacies and about pharmacies konsesjonærens interaction to further and continuing education.
§ 4-4. Expedition and handling of medicinal products Only the chemist's pharmaceutical staff have the right to independently to dispatch medicines for prescription and requisition that after the current extradition provisions shall be subject to the pharmaceutical control.
All handling of drugs shall be conducted under the supervision of the pharmacy's pharmaceutical staff. It should ensure that the current regulations are followed and that the work by the way is carried out professionally prudent.
§ 4-5. Cooperation with the health care provider if the customer needs warrant, to professional conduct in pharmacies happen by collaboration and interaction with other qualified health care professional.
section 4-6. Practical training in the practice of Pharmacy Technician Students education in high school, reseptar and pharmacy students and pharmacists with foreign education to take Norwegian additional try, has the right to the practical training in pharmacy that the Ministry has approved that practice pharmacy.
The Ministry determines the pharmacy that is practice Pharmacy and who is obliged to receive pupils and students to the practical training. The Ministry may give further provisions on the course length and content.
Kap. 5. Basic requirements for pharmacy business section 5-1. Premises, furnishings and equipment should be the chemist's premises designed, furnished and equipped well enough to ensure the good quality and high security in the pharmacy's storage, manufacture, expedition and the provision of medicines. Lokalenes design, furnishings and equipment should be adapted to the professional and technical development.
The pharmacy's audience should be delimited zone unique and suitable to attend to the public's need for discretion. Pharmacies konsesjonæren have access to the parts of the pharmacy that is not the public's zone after permission from the pharmacist or pharmacy manager.
The Ministry may by regulation provide further provisions on the chemist's premises, furnishings and equipment, and on securing the premises, etc., as well as rules on notification and approval by the rebuilding of the premises.
section 5-2. Opening and closing times the pharmacy should be open for the expedition and the provision of drugs to the public within their opening times. If not otherwise laid down pursuant to the second paragraph, it says the pharmacy free to decide their opening and closing times.
The Ministry may by regulation determine the minimum opening hours of pharmacies, and can also determine the closing times on Sundays. In the regulation may also be given provisions on the duty of reporting and announcement of opening hours.
section 5-3. Negotiation duty Pharmacy has the duty to negotiate: a) all drugs that are allowed sold here in country b) common medical equipment used by consumers.
The Ministry may provide regulations that determine which articles or product groups covered by the first paragraph. The Ministry may also provide provisions that restrict and extend bargaining obligation.
§ 5-4. Item deliveries, inventories and delivery so the pharmacy shall have procedures for the supply of goods to ensure fast delivery to the warehouse of goods covered by the bargaining obligation. The chemist's medicines can only come from approved wholesaler or from other business that has the Ministry's permission to sell drugs to pharmacies. Pharmacies with the same pharmacies the concessionaire can deliver drugs to each other, unless the Ministry decides otherwise in the regulations.
The casual on-hand inventory will stand in relation to the nature and extent of the pharmacy's turnover. The pharmacist should always have stock of the negotiating items that rekvireres obliged regularly or sought by doctors, dentists, veterinarians and other health professionals on site.
The pharmacy shall register the demand and provision of drugs at the pharmacy, so that the delivery rate going forward.
The Ministry may provide regulations on which items should always be a pharmacy have in stock and set minimum requirements to the delivery rate for drugs. It may also be given provisions regarding pharmacy duties upon receipt of the drugs from the supplier and on the access for pharmacies to deliver drugs to each other.
section 5-5. Accounting and other business registration to have separate budget Drugstore and accounting. The financial statements shall be properly and completely according to the fiscal duty that applies to your business.
The Ministry may by regulations provide further provisions on the fiscal obligation and can fix the addition to the financial obligation that is required. The pharmacy can also be ordered to lead other tasks across their business than those that follow of the financial obligation.
The financial statements and other information that the pharmacist is obliged to register, to be made available to the Ministry. The Ministry may give further provisions about how the pharmacy to keep the information and make them available.
section 5-5 a. documentation of the prescription to the pharmacy expedition keep information about the expedition and the provision of medicines and merchandise after the prescription and requisition. The Ministry further gives provisions for such registration, including requirements for retention periods and what should be registered.
For patients ' right of access in stored information applies to patient and user rights.
section 5-6. Internal control the pharmacy shall establish internal control for the business and must be able to document that the activities and services are planned, carried out and maintained in accordance with the requirements set out in the Act and the regulations.
The Ministry may by regulation provide further provisions on internal control in pharmacies.
section 5-7. The dissemination of public information the pharmacy duties to assist in the disclosure of public information about medicines, medical equipment and the like.
section 5-8. Closure of pharmacies By closure to the pharmacy's owner to ensure safe treatment of drugs, relevant documentation and personal information that is kept or stored in the pharmacy. The Ministry may by regulation provide further provisions on requirements in connection with the closure.
Kap. 6. Sales and marketing from the pharmacy section 6-1. Delivery right for the chemist's goods, etc. with the limitations, the pharmacist has imposed by law and regulation the right to deliver goods and provide these negotiation obliged the services arising out of the negotiation the obligation. Pharmacies can also deliver and provide other goods and services if it is natural and appropriate irreconcilable with the pharmacy's sales of goods by virtue of your negotiation. The Ministry can still provide access to regulations that restrict to sell items and item groups not covered by the bargaining duty, and can provide provisions which restrict freedom to provide services other than pharmaceutical services.
The Ministry may provide regulations that restrict the pharmacy's access to the shipment of drugs.
The Ministry may by regulation and in each case in whole or in part except hospital pharmacies from the delivery right for negotiating obliged goods to other customers than the hospital and the hospital staff and users.
§ 6-2. The delivery obligation for the negotiation, etc. will be under a duty Pharmacy goods as soon as possible deliver goods and provide services as requested and as covered or follows from the bargaining obligation.
Pharmacies do not have access to deliver when the disclosure involves violations of the current extradition provisions and it is not allowed to make exceptions. The same applies when: a) prescription drugs drug required dispensed on the basis of faulty prescription and the terms of the emergency provisions for current output expedition no b) medication requested of the person who according to the message from the Government is not to be divulged specific drugs or c) the pharmacist has reason to believe that the medication can be misused or pose a danger if it divulged.
The delivery obligation applies even if payment is not included and security not be set, if the pharmacy on prescription or otherwise advised by the attending physician or dentist that the medication be needed right away.
section 6-3. Delivery of medicines from medicine outlets can be delivered from Drugs medicine outlets to the extent it is determined in the regulations. The Ministry provides regulations on which drugs this is true, and can provide further rules for medicine retail outlets with requirements for premises, staff, bestyrelse, extradition, etc.
section 6-4. Price disclosure if more drugs are equal negotiation, obliged to inform the customer about the pharmacy cheapest option, unless the price difference is negligible. Equal to prescription drugs are drugs that are exchangeable under section 6-6 the second paragraph.
section 6-5. Drug information All drug information provided in, from and on behalf of pharmacies to clients, health professionals and the public to ensure the consideration of otherwise proper and correct use medical drug. It is prohibited to design, provide and otherwise disclose information about medicines that can contribute to the abuse, misuse or overuse.
section 6-6. The provision of drugs for Prescription Drugs and requisition will be divulged exactly after the prescription and requisition.
The pharmacy can conclude the first paragraph change requested the drug with generic equivalent drug and with parallel imported medicinal product if the Ministry has approved medicines are as exchangeable. Such a change may not happen in violation of the requisitioner's or the customer's explicit wish. If the requisitioner requests it, to announce that the pharmacist the requisitioner such a switch is made.
The Ministry may by regulation provide further provisions that the requisitioner in the individual case shall journalize a justification for that generic switch after the second paragraph is undesirable.
By disclosure against the prescription to the pharmacy help that customer get adequate information about the medication to be used properly.
section 6-7. The provision of drugs without a prescription at the sale to the general public of medicinal products which can be extradited without a prescription, the pharmacy help ensure that the customer gets necessary information about the medication, including check that: a)
medicine is provided with sufficient information about the use, storage and shelf life b) the customer has sufficient information about the medication to be used correctly and c) the customer is informed about the possible harmful effects.
section 6-8. Extradition provisions the Ministry provides regulations with provisions on closer the provision of medicines from pharmacies.
section 6-9. Complaints and alert duty by errors and quality is missing the pharmacy to lead list of all complaints on the drugs that the Pharmacy has dispensed. The complaint should be investigated immediately, and the necessary steps should be undertaken: a) in case of error and quality missing on resold preparations notify to legemidlets supplier or importer.
b) if it can be assumed that the use of a apotektilvirket drug could lead or have led to health damage, the supervisory authority shall immediately be notified, and the steps necessary to avert or minimize the damage should be taken.
The first paragraph also applies if the errors or quality deficiencies in drugs uncovered in the pharmacy before the disclosure.
section 6-10. Return medicine Pharmacy duties in consumer purchases to take back drugs for the kassasjon at no cost to the customer.
The Ministry may give further provisions on the receipt, storage and kassasjon of return medicine. ""
section 6-11. Marketing exposure of the chemist's goods to the public will be dominated by items that belong in the pharmacy's duty under negotiation.
The pharmacy can with the limitations provided in the law and regulations, market their goods, services, prices, discounts, and delivery terms.
Only items covered by the bargaining duty, can be marketed in General that items that are available at pharmacies. Other items can only be associated with pharmacies along with indication of which pharmacies as a dealer item.
The Ministry may give further provisions on the marketing of goods and services, apoteks including provisions that restrict access to the marketing for this paragraph.
section 6-12. (Repealed by law 19 June 2009 No. 71 (ikr. 1 jan 2010 according to. res. June 19, 2009 No. 689).)
Kap. 7. Production of medicines in pharmacies section 7-1. The right to manufacture the Ministry may give pharmacies the concessionaire supplier of permission for pharmacies that meet the criteria for such permission. For manufacture outside pharmacies can permission is granted to other than pharmacies the concessionaire if the workmanship is happening on a mission from the pharmacy. The Ministry provides regulations with provisions on closer which requirements that must be met in order to get permission, and supplier about the revocation of the permit.
The Ministry may prohibit the manufacture or storage of certain drugs and goods in pharmacies.
section 7-2. Manufacturing standard production of drugs for this chapter to be prudent and in accordance with good manufacturing practice. The Ministry may by regulation provide further provisions on the quality and safety requirements.
section 7-3. The sale of apotektilvirkede drugs Pharmacy has the right to sell drugs to egentilvirkede the end user in the pharmacy that are covered by the operating licence.
Medicines that are manufactured after the individual prescription, may be sold to or through the pharmacies of the business with the supplier of permission as rent producer for resepturproduksjon. Unless otherwise follows from the agreement, responding manufacturer for hire legemidlets composition, durability, packaging and delivery to the receiving pharmacies.
Medicines that are manufactured to the inventory, can only be sold to pharmacies and to the wholesaler on the basis of special permission from the Ministry. Permission can be granted for a limited period of time and on closer terms, which can be changed after permission is granted. Pharmacies with permission to the sale of the inventory production after this part may be ordered delivery duty of pharmacies and wholesaler for drugs covered by the permit.
The Ministry may give further provisions on sale, including ordering, receiving and delivery, of apotektilvirkede drugs.
Kap. 8. Supervision of the pharmacies section 8-1. The supervisory authority is the Ministry of supervisory authority and oversees that the requirements for pharmacy business in the law and regulations are met.
section 8-2. The duty of the interaction The which is subject to supervision, is obliged to make sure that the supervisory authority has unhindered access to pharmacies. The supervisory authority shall further be given the necessary access to the section of Pharmacy konsesjonærens business that is related to the operation of pharmacies.
The supervisory authority may impose pharmacies the pharmacist konsesjonæren, and the pharmacy's on-site manager, or representatives of these, to be present during the audit.
The supervisory authority shall have access to the necessary documentation and free of charge can take out drugs and other goods to further investigation and control.
section 8-3. Order correction If the pharmacist or pharmacy konsesjonæren do not meet the requirements of the business set out in the law and regulations, the supervisory authority can issue an order for rectification within a prescribed time limit.
section 8-4. Warning By inadequate or irresponsible operation supervisory authority can give warning, even if the relationship is directed at or have been of transient character.
Decision warning is considered to be individual decisions and be directed both to the pharmacies konsesjonæren and to the pharmacist. When special reasons exist, the warning should be directed only to the pharmacies konsesjonæren.
section 8-5. Closing the supervisory authority can shut the Pharmacy and medicine outlets if the absence of such a licence or permit that the law restricts, or if your business can result in substantial danger to health and safety. By closure may be required that the premises be sealed.
The supervisory authority may, if necessary, require the assistance of the police to enforce the closure and seal.
Kap. 9. Administrative provisions and penalties § 9-1. Complaint authority in certain matters the King may decide that the State's health care Committee to be complaint authority for decision after kap. 3 to 9 which is made by the subordinate body by virtue of the law or by delegation from the Ministry.
In such cases the Committee call themselves Complaints Committee Pharmacy. By the way comes to sections 69 and 70 of the law on health personnel, etc. (helsepersonelloven) about the Committee's organization and business.
section 9-2. Fees the Ministry may provide regulations on fees for the processing of the application for a pharmacy licence for kap. 2 and the operating concession for kap. 3. section 9-3. Coercive to ensure that the criteria given under section 2-8, duties, pursuant to section 5-5 as well as an order given under section 8-3 are met, the supervisory authority may decide that the pharmacy will be paying an ongoing coercive for every day that passes after the expiry of the deadline set for meeting your relationship, until they are satisfied. Decision on the coercive is enforceable for disbursements.
section 9-4. (Repealed by law 11 jan 2013 No. 3 (ikr. 1 June 2013 CISPR. 24 may 2013 No. 533).)
section 9-5. Penalty it as intentionally or negligently contravenes sections 1-4, 1-5, 2-10, 3-7, 5-5, 6-5, second sentence, 6-9, 6-11, 6-12, 7-2 the first paragraph and 8-2, is punishable by fines or imprisonment up to 6 months.
Kap. 10. Entry into force. Transition rules § 10-1. Entry into force the law will take effect from the time that the King decides. 1 the King may decide that the individual provisions of the law to take effect to a different time.
From the same time repealed law 21. June 1963 No. 17 on the operation of pharmacies, etc.
section 10-2. Older regulations Regulations given in pursuance of law 21. June 1963 No. 17 on the operation of pharmacies etc. also applies after the law here has taken effect.
§ 10-3. Older licenses Bevillingshavere to the pharmacy that was legally established as independent pharmacies by this Act, entry into force, be given without new application processing pharmacy licence and operating licence on the terms associated with the grant. The same applies for medicine outlets and for the supplier of permission given in relation to the grant. For the licence given to the municipality, County Council and State to the operating concession is considered to lie with the pharmacist added.
Bevillingshavere to the pharmacy that was legally established as branch pharmacies by this entry into force of the law, is provided without new application processing pharmacy licence on the terms associated with the grant. It added the manager shall be deemed as apothecary to the branch the Pharmacy and have the title pharmacies, if the terms in section 3-2 the first paragraph is met. If the branch manager the chemist's do not meet the criteria for its own operating licence, to branch is considered to be under the pharmacist operating the concession to the pharmacies that by the entry into force was licence holder to branch the pharmacy, and the Manager should have the title pharmacy manager and deemed approved pursuant to section 4-2.
§ 10-4. Older Pharmacy and medicine outlets---section 10-5. Changes in other laws, with effect from the entry into force of the law be made the following changes in other laws:-
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