Pharmaceutical Regulation (2015:458)

Original Language Title: Läkemedelsförordning (2015:458)

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2015:458

/Entry into force: 01/01/2016

Chapter 1. The scope of the



Content



paragraph 1 of this regulation are supplementary provisions to the medicines Act (2015:315).



Expression of the regulation



section 2 of the terms used in the medicines Act (2015:315) has the same meaning in this regulation.



The application in some cases



section 3 For a homeopathic medicine that can be registered under the medicines Act (2015:315), the following provisions shall not apply to:



– Chapter 1 section 4, if the traditional herbal medicinal products,



– Chapter 2. 3, 5, 6, 10 and 11 sections, and sections 14 and 15, concerning certain questions relating to the approval and registration of sales,



– Chapter 3. 1 to 9, 11 and 12 sections, if security monitoring and control,



– Chapter 4, on clinical drug trial,



– Chapter 6. section 5, on notification by the parallel distribution,



– Chapter 8. paragraphs 1 and 2, if the immunological veterinary medicinal products, and



– Chapter 9 section 2 and section 3 1, with appropriations.



4 section For a traditional herbal medicinal product can be registered under the medicines Act (2015:315), the following provisions shall not apply to:



– Chapter 1 section 3, if the homeopathic veterinary medicinal products,



– Chapter 2. paragraphs 3 and 4, paragraph 5, 6 and 14 sections, about some questions concerning marketing authorisation,



– Chapter 3. 9, 10 and 12 sections, if some questions regarding safety monitoring and control,



– Chapter 6. section 5, on notification by the parallel distribution,



– Chapter 8. paragraphs 1 and 2, if the immunological veterinary medicinal products, and



– Chapter 9 paragraphs 1 and 2 and paragraph 3, with appropriations.



The provisions of Chapter 4. shall only apply where the MPA pursuant to Chapter 4. paragraph 5 of the medicines Act imposed on a claimant to submit to it the results of clinical drug trials.



section 5 For a medicinal product falling within the scope of the hospital exemption, the following provisions shall apply mutatis mutandis:



– Chapter 1 section 2, if statements in the regulation,



– Chapter 3. 4, 11 and 14 sections, about some questions regarding pharmacovigilance,



– Chapter 5., on the manufacturing,



– Chapter 7. 1, 2 and 4 of section, regarding time limits for decisions and the disclosure of information,



– Chapter 8. section 3(1), 4 and 6 §§, appointment, agents and certificate, and



– Chapter 9 3 § 1, 4 – 6 § § § 2, 9, 11 and 12 sections, with appropriations.



As provided in Chapter 3. the first and second subparagraphs of paragraph 7 and section 13 shall also apply to the authorised to manufacture a medicine covered by hospital exception.



The FDA may decide in individual cases as provided in Chapter 3. the first and second subparagraphs of paragraph 7 and which is prescribed in Chapter 6. 2 and 3 of the medicines Act (2015:315) should not apply to those who have permission to manufacture a medicine covered by hospital exception.



Chapter 2. Authorisation, registration and authorisations for the marketing of medicinal products



Application



Article 1, only those who have a permanent establishment for their activity in the European economic area (EEA) may apply for 1. authorisation or registration in accordance with Chapter 4. 2, 4, 5 or 9 of the medicines Act (2015:315),



2. recognition of an authorisation or a registration for sale in another EEA country pursuant to Chapter 4. 6 or 7 of the medicines Act, or



3. authorization for sale pursuant to Chapter 4. section 10 of the medicines Act.



Documentation to be attached to an application



section 2 of such documentation as the agency determines should be annexed to an application for



1. the authorisation or registration in accordance with Chapter 4. 2, 4, 5 or 9 of the medicines Act (2015:315),



2. recognition of an authorisation or a registration for sale in another EEA country pursuant to Chapter 4. 6 or 7 of the medicines Act,



3. authorization for sale pursuant to Chapter 4. section 10, second paragraph the medicines Act, or



4. the renewal of a marketing authorisation as referred to in Chapter 4. section 17 of the medicines Act or re-registration for sale.



Certain exemptions from the requirements for documentation



section 3 except as provided in Chapter 4. section 13 medicines Act (2015:315), the Agency may grant exemption from the requirement that the applicant submits documentation of results of preclinical studies and clinical trials on



1. the applicant shows that the active substances of the medicinal product applied for shall have had a well-established medicinal use within the EEA for at least ten years, with recognised efficacy and an acceptable level of safety which corresponds to the conditions laid down in annex I to Directive 2001/83/EC of 6 november 2001 on the Community code relating to medicinal products for human use, in wording as laid down in Commission directive 2009/120/EC , or in annex I to Directive 2001/82/EC of 6 november 2001 on the Community code relating to veterinary medicinal products, in wording as laid down in Commission directive 2009/9/EC,



2. the medicinal product applied for shall contain combinations of such active substances included in the composition of authorised medicinal products, but not used in combination with each other, or



3. the medicinal product applied for shall have the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the previously approved medicinal products, and the marketing authorisation holder admits that the documentation on which approval may be relied on by the applicant.



In the case referred to in the first subparagraph 3, the exceptions to the requirement that the applicant submits documentation is granted also in the case of results of pharmaceutical research.



Special conditions in the decision granting the marketing authorisation



section 4 of the special conditions in a decision on the marketing authorisation for a medicinal product pursuant to Chapter 4. section 2 of the medicines Act (2015:315) shall be designed in accordance with the provisions on conditions for authorisation set out in Annex i to Directive 2001/83/EC, in wording as laid down in Commission directive 2009/120/EC or in annex I to Directive 2001/82/EC, in wording as laid down in Commission directive 2009/9/EC.



In addition to what is stated in the first paragraph, a decision concerning the authorisation of a medicinal product for human use is combined with



1. the conditions that some of the measures included in the risk management system and to ensure the safe use of the drug should be taken,



2. the condition that it should be done safety studies after the drug has been approved,



3. conditions to be impact studies after the drug has been approved, if there is suspicion of efficacy and such suspicions can be removed only after the product has been placed on the market;



4. provided that there is an effective pharmacovigilance system,



5. conditions for registration or reporting of suspected adverse reactions to the drug, and



6. other conditions or restrictions necessary to the safe and effective use of the drug should be taken.



Reports



paragraph 5 of the decision granting the marketing authorisation of a medicinal product for human use shall state how often the authorisation-holder shall submit periodic safety update reports. Date of submission of the reports shall be calculated from the date of the marketing authorisation.



To determine the frequency of periodic safety update reports shall be submitted for a medicinal product for which it has been granted a different marketing authorisations, but containing the same active substance or combination of active substances, the Agency shall apply the procedure referred to in article 4 (6) of Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive 2010/84/EU.



6 § When the FDA has approved a drug for sale to work developing an assessment report on the medicinal product. The assessment report shall contain 1. the results of the pharmaceutical tests;



2. the results of preclinical studies,



3. the results of clinical drug trials,



4. information on risk management systems, and



5. information on pharmacovigilance of the medicinal products.



If the report concerns a medicinal product for human use shall also include information on whether the marketing authorisation is subject to conditions of use of the product and a summary of the report.



The assessment report shall be updated if there is any new information which is of importance for the evaluation of the quality, safety and efficacy.



Recognition of an authorisation or a registration of a medicinal product which has been granted in another EEA country



section 7 At the examination of an application pursuant to Chapter 4. 6 or 7 of the medicines Act (2015:315) on the recognition of such approval or registration for the sale of a medicinal product which has been granted in another EEA country, the medical products agency, within 90 days from the date that the work received the dossier prepared by the country that has announced approval or registration (reference Member State), verify whether the dossier is to be approved. The dossier shall be approved if it is not necessary to assume 1. that medicinal product might pose a serious risk to public health, or



2. that the veterinary medicinal product might pose a serious risk to human or animal health or for the environment.



If the agency finds that, in the examination dossier shall


be approved and all interested Member States are unanimous in this assessment, the Agency announce decision to recognise the authorisation or registration within 30 days of the agreement.



The decentralised procedure



section 8 of the FDA, in a decentralised procedure as referred to in Chapter 4. the second subparagraph of paragraph 9 of the medicines Act (2015:315) within 90 days from the date that the work received the dossier prepared by the reference Member State shall verify whether the dossier is to be approved. The dossier shall be approved if it is not necessary to assume 1. that medicinal product might pose a serious risk to public health, or



2. that the veterinary medicinal product might pose a serious risk to human or animal health or for the environment.



If the FDA's analysis finds that the dossier is to be accepted and all interested Member States are unanimous in this assessment, the work announce the decision to authorise or register the product within 30 days of the agreement.



Coordination procedure, section 9 Of the FDA's analysis under section 7 or 8 determines that the base cannot be approved, the Agency provide detailed reasons for its position to the reference Member State, other interested Member States and the applicant. In such a case, or when the consensus on this issue would not exist between all interested member countries, the Agency participate in a proceeding in such a coordination group referred to in article 27 of Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive 2010/84/EC, or article 31 of Directive 2001/82/EC , in wording pursuant to European Parliament and Council Directive 2004/28/EC.



During the coordination procedure provided for in article 29(3) of Directive 2001/83/EC, in wording pursuant to European Parliament and Council Directive 2004/27/EC or under article 33(3) of Directive 2001/82/EC, in wording pursuant to European Parliament and Council Directive 2004/28/EC, the Agency does not grant or refuse the application.



If agreement is reached between the Member States, the Agency shall decide in accordance with the opinion of the coordination group within 30 days of the agreement.



section 10 of the food and Drug Administration Decides to approve, register at the request of the applicant, or to recognise an authorisation or a registration for sale in another country after such a procedure, as referred to in section 9, ended without a consensus reached, but before the European Commission announced a decision as referred to in article 34(1) of Directive 2001/83/EC , in wording pursuant to European Parliament and Council Directive 2004/27/EC or in article 38(1) of Directive 2001/82/EC, in wording pursuant to European Parliament and Council Directive 2004/28/EC, it shall by decision shall state that it is subject to change as a result of the Commission's decision.



section 11 if the European Commission announced a decision as referred to in Chapter 4. paragraph 6, third paragraph, Chapter 4. the third subparagraph of paragraph 7 or Chapter 4. the second subparagraph of paragraph 9 of the medicines Act (2015:315), the national agency decision under those provisions will be announced within 30 days of the Commission's decision.



Comply with the Commission decision, such a decision of the Agency referred to in section 10 does not, however, any further decision by the Office.



Obligations when Sweden are the reference Member State



section 12 If a medicine has been approved or registered for sale by the FDA to work, at the request of the holder of the authorisation or registration and that in another country within the EEA applied for recognition of authorisation or registration, perform the obligations incumbent upon a reference Member State under articles 28(2) and 28(4) of Directive 2001/83/EC, in wording pursuant to European Parliament and Council Directive 2004/27/EC , or in articles 32(2) and 32(4) of Directive 2001/82/EC, in wording pursuant to European Parliament and Council Directive 2004/28/EC.



paragraph 13 of such data to the FDA to draw up pursuant to Chapter 4. first paragraph of section 9 of the medicines Act (2015:315) should contain proposals for



1. assessment report, 2. Summary of the drug's properties, 3. labelling, and



4. the package leaflet.



The substrate should be completed within 120 days from the date that the applicant come in with a request to the FDA that Sweden will act as reference Member State. When the surface has been completed, work send it to the applicant.



Obligations of the competent authority in certain cases



section 14 of the food and Drug Administration to fulfill the obligations of a competent authority in accordance with article 6(2) of Directive 2001/82/EC, in wording pursuant to European Parliament and Council Directive 2004/28/EC.



Request for an opinion, reference and leading and participating in certain procedures



section 15 of the MPA may 1. shall request the opinion of the Committee for herbal medicinal products as referred to in article 16 c (1) (c) of Directive 2001/83/EC, in wording pursuant to European Parliament and Council Directive 2004/24/EC,



2. refer a question about an herbal product to the Committee for herbal medicinal products as referred to in article 16 c (4) of the European Parliament and Council Directive 2001/83/EC, in wording pursuant to European Parliament and Council Directive 2004/24/EC,



3. initiate and participate in proceedings referred to in article 34(1) and 35(1) of Directive 2001/82/EC, in wording pursuant to European Parliament and Council Directive 2004/28/EC, and article 40 of Directive 2001/82/EC, in the original wording, and in article 30(1) and (2) of Directive 2001/83/EC , in wording pursuant to European Parliament and Council Directive 2004/27/EC, and article 31(1) of Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive 2010/84/EU.



Permission to use in the other cases



section 16 questions about permits for the sale of a Center with funds pursuant to Chapter 4. 10 of the medicines Act (2015:315) be considered by the Government. Authorization for certain period of time and may be subject to conditions for the protection of the individual.



section 17 of the authorisation of the sale of a medicine according to Chapter 4. section 10, second paragraph the medicines Act (2015:315) must be notified in order to meet the special needs of pharmaceuticals in health care or in the veterinary activities. Questions about such conditions are tested by the FDA. Authorisation may be granted for a certain period of time and may be subject to conditions for the protection of the individual.



Chapter 3. Security monitoring, control and withdrawal



The Swedish medical products Agency's pharmacovigilance system



section 1 of the Swedish medical products Agency's pharmacovigilance system of medicinal products for veterinary use shall be in accordance with the guidelines referred to in article 77 of European Parliament and Council Directive 2001/82/EC, in wording pursuant to European Parliament and Council Directive 2004/28/EC.



section 2 of the FDA, as part of the pharmacovigilance of medicinal products for human use



1. enable and facilitate for consumers and health care professionals to report suspected adverse reactions to medicinal products to the FDA,



2. ensure that data of the scientific evaluation of reports of suspected adverse reactions to medicinal products are precise and controllable, and



3. implement measures to identify biological medicinal product which is the subject of a report of a suspected side effect and that are prescribed, be disclosed or sold in Sweden.



section 3 of the FDA, on its Web site to provide information on medicinal products with the following content



1. public assessment reports, summaries of product characteristics and patient information leaflets,



2. summaries of risk management plans,



3. a list of the medicinal products referred to in article 23 of Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, in wording according to Regulation (EU) no 1027/2012,



4. disclosure of how consumers and health care professionals to report suspected adverse reactions to medicinal products to the FDA, and 5. a link to the Web-portal referred to in article 26 of Regulation (EC) No 726/2004, the wording according to Regulation (EU) no 1235/2010.



section 4 of the food and drug administration, by evaluating the periodic safety update reports submitted to determine whether there are new risks, on the risks have changed, or if the relationship between the benefits and risks of the drug has changed.



Coordination procedure



paragraph 5 of The coordination procedure referred to in articles 107e and 107 g of European Parliament and Council Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive 2010/84/EU, is used to assess periodic safety update reports for



1. medicinal products authorised or registered in more than one country within the EEA, and




2. medicinal products for human use containing the same active substance or combination of active substances for which a reference date and filing range of the EEA has been established.



The FDA should fulfil the obligations Member States have under the articles of the directive.



section 6, if it is necessary to carry out urgent action because of suspicion about the security risks of a medicinal product for human use, the agency initiate the coordination procedure referred to in articles 107i and 107j of European Parliament and Council Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive/26/EU and article 107 k in European Parliament and Council Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive 2010/84/EU If the work



1. considering that suspend or revoke an authorisation or a registration for sale,



2. is considering banning the supply of a medicinal product for human use or to reject an application for renewal or re-registration for sale,



3. get information on to a holder of an authorisation or a registration for sale has ended with the sale of a medicinal product for human use or taken or intends to take measures to withdraw approval or registration for the sale, or



4. is of the opinion that an authorisation or a registration shall be changed.



If the procedure is initiated, the MPA perform the obligations which the Member States have under the articles of the directive.



Responsibilities of the holders of the authorisation or registration for sale



section 7 of the holder of an authorisation or a registration of medicinal products shall keep records of all information concerning suspected adverse reactions to the medicinal product in the EEA or in non-member countries and to the holder's knowledge. The holder shall report all such side effects in accordance with regulations that the FDA can notify pursuant to Chapter 9. section 12.



If a holder of an authorisation or a registration for sale becomes aware of circumstances which constitute grounds for believing that the information or documents which are the basis for authorisation or registration is not real or should be completed, he is obliged to immediately report it to the FDA.



The holder of an authorisation or a registration for the sale of a medicinal product for human use shall report the new risks or risks that have changed, or changes in the relationship between the benefits and risks of the drug to the FDA and the European Medicines Agency.



§ 8 the holder of an authorisation or a registration for the sale of a medicinal product for human use shall maintain a detailed description of the pharmacovigilance system which the holder uses one or more approved or registered medicinal products (pharmacovigilance system master file).



The holder shall, upon request of the Agency a copy of the description of the pharmacovigilance system referred to in the first subparagraph to the work. Such copy shall be submitted to the Office within seven days after the owner has received such a request.



Non-interventional studies on safety



section 9 If the holder of a marketing authorisation for a medicinal product for human use has received an authorisation as referred to in Chapter 6.

section 7 of the medicines Act (2015:315), the holder shall submit the approved the Protocol for the study to the FDA before the study is initiated.



If there is a follow-up of the results of a non-Interventional safety coordination according to the procedure referred to in article 107q of Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive 2010/84/EU, FDA should fulfil the obligations Member States have under article.



section 10 of the food and Drug Administration may, for such studies as referred to in Chapter 6. first subparagraph of paragraph 6 of the medicines Act (2015:315), on a case by case basis, decide on exemptions from the requirement of the final report in Chapter 6. paragraph 5 of the second paragraph of the same law.



Information obligation in respect of products covered by the hospital exemption



section 11 of the food and drug administration, in the case of a medicinal product covered by a hospital except inform



1. The European Agency for the evaluation of suspected adverse reactions to the medicinal product,



2. the authorities of the countries within the EEA is responsible for the implementation of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Directive 2004/23/EC of 31 March 2004 on setting standards of quality and safety for the donation, , procurement, testing, processing, preservation, storage and distribution of human tissues and cells, if serious complications or side effects caused by the drug, if it contains one or more medical devices, and



3. the authorized to manufacture the drug and hospitals who have used the drug about suspected adverse reactions to the drug.



If the information referred to in the first subparagraph 1 and 3 relate to serious suspected adverse reactions, shall be made within 15 days after the work has been made aware of the suspicion. Refers to information non-serious suspected adverse drug reactions should it instead be submitted within 90 days after the work has been made aware of the suspicion.



If the FDA, after evaluating data relating to pharmacovigilance, finds that the conditions for the manufacture of a drug covered by the hospital exemption should be suspended, repealed or amended to the work, without delay, inform the authorized to manufacture the medicine about this.



System of registration of medicinal products that are deemed to be counterfeit or to have quality defects section 12 of the FDA is responsible for a system to receive and manage notifications relating to medicinal products for human use which are deemed to be counterfeit or to have quality defects.



Exemptions from the Privacy Act section 13 the MPA and the holder of an authorisation or a registration for the sale, despite the provisions of the second subparagraph of paragraph 13 of the personal data Act (1998:204) perform the treatments of personal data relating to health and which are necessary to perform the obligations provided for under the medicines Act (2015:315) or in this regulation.



The MPA is personal responsible for processing personal data which performs in order to fulfill such obligation referred to in the first subparagraph.



Health data registers



section 14 of the food and Drug Administration may bring health data registers under section 1 of the Act (1998:543) on health data registers to meet the need of information for the purposes set out in Chapter 6. section 1 of the medicines Act (2015:315) as well as for the production of statistics and research.



Chapter 4. Clinical drug trial



Application for permit



section 1 of the application for authorisation of a clinical drug trial shall be made by the person, company, institution or organisation that is responsible for initiating, organizing and possibly funding the trial.



It required the written permission to begin clinical trials referred to in Chapter 7. the fourth paragraph of article 9 of the medicines Act (2015:315).



Injunction to remedy the deficiency



section 2 of the FDA Finds that the authorisation of clinical trials or anyone else involved in that examination deficiencies in their obligations, the Agency shall submit to him to remedy the deficiency.



Agency shall without delay inform the Ethics Review Board that approved the drug trial, the competent authorities of the other countries in the EEA and the European Commission on the content of the orders referred to in the first subparagraph.



Notice on revocation



section 3 of the FDA Decides to revoke a permit if the clinical trials notified or to be deemed granted under Chapter 7. § 9 the first or third paragraph the medicines Act (2015:315), should work without delay inform the Ethics Review Board that approved the drug trial, the competent authorities of the other countries within the EEA, the European Medicines Agency and the European Commission.



The European database for clinical drug trials, paragraph 4 of the food and drug administration, the European database for clinical drug trials, Eudract, record data 1. provided in the application for authorisation referred to in Chapter 7. § 9 the medicines Act (2015:315) and about the changes that are made in such applications,



2. If the amendments to the Protocol,



3. If an ethical review Committee's decision to approve a clinical drug trial,



4. about a clinical drug trial has been completed, and



5. If an inspection of how good clinical practice are complied with.



Disclosure section 5 MPa shall, at the request of one or more countries within the EEA, the European Medicines Agency or the European Commission to disclose such data about clinical drug trials from applications that are not available in the database referred to in paragraph 4.



If the requested part of the data do not have reasons for


their request and the information covered by the obligation of professional secrecy referred to in publicity and secrecy (2009:400), however, the data are not disclosed.



Chapter 5. Manufacturing



Permission to manufacture



section 1 Authorisation in accordance with Chapter 8. 2(1) of the medicines Act (2015:315) shall be granted for a specified period or until further notice and refer to a particular or certain medicinal products or intermediate products, or drugs or intermediate products in General.



Withdrawal



section 2 of the manufacturing authorization, suspended or revoked in the case of a category of preparations or all preparations or intermediate products that permit, if any of the requirements that apply to a licence should be granted are no longer fulfilled.



Supervision report



section 3 of the FDA will establish a report when the work has carried out an inspection of a 1. manufacturers of medicinal products or intermediate products, or



2. the manufacturer, importer or distributor of active substances intended for human use.



In the report to the work report of the inspected comply with good manufacturing practice for medicinal products or active substances or good distribution practice for active substances in accordance with EU legislation, as appropriate, on the one hand, the other requirements of the business.



Within 90 days of an inspection as referred to in the first paragraph have been completed, the work will draw up a certificate for the inspected if applicable good practice in accordance with Union law, what has emerged during the inspection shows that the inspected follows such practice.



Chapter 6. Import and other admission



Conditions for special permission to import



section 1 of the special permit for the importation of products referred to in Chapter 9. 1 paragraph 1 the medicines Act (2015:315) may be granted



1. the permit referred to in Chapter 2. section 1 of the Act (2009:366) on trade in drugs to carry out retail trade in medicinal products, or 2. the authorized pursuant to Chapter 3. paragraph 1 of the law on trafficking in drugs to engage in activity as a wholesaler in medicinal products.



section 2 of the Special conditions for the import of products referred to in Chapter 9. 1 paragraph 2 the medicines Act (2015:315) may be granted



1. the Superintendent of a scientific institution or equivalent at a university or college or for such investigation laboratory, research institutes, etc., that are owned or are enjoying the support of the State or municipality, or 2. individual engaged in scientific research or development work on a scientific basis or who assist such activities.



section 3 of the special permit for the importation of products referred to in Chapter 9. 1 paragraph 3 the medicines Act (2015:315) may only be granted in their organization has access to such specialist referred to in Chapter 8. Article 1, first paragraph the medicines Act.



Withdrawal



section 4 of the special permit to import, suspended or revoked in the case of a category of preparations or all preparations which State, if any of the requirements that apply to a licence should be granted are no longer fulfilled.



Intelligence at the intention of the parallel distribution 5 § The intending to as part of the trade include a drug that is approved for sale under European Parliament and Council Regulation (EC) No 726/2004, to Sweden, but who is not the holder of the authorisation, shall inform the authorisation holder and the European Agency for the evaluation of its intention.



Chapter 7. Provisions on time limits for decisions and disclosure of



information



Certain time limits



paragraph 1 of the Decision by the FDA under the medicines Act (2015:315) be in the specified cases within the times shown in the table.



Type of decision number of days



Notification of marketing authorization of medicinal products pursuant to Chapter 4. section 2 of the medicines Act 210



Decision on registration of the sale of homeopathic medicine pursuant to Chapter 4. section 4 of the medicines Act 210



Decision on registration of the sale of traditional herbal medicinal products pursuant to Chapter 4. paragraph 5 of the first paragraph, the medicines Act 210



Decisions on such a renewal of marketing authorisation for medicinal products referred to in Chapter 4.

section 17 of the medicines Act and re-registration for sale 180



Decision on authorisation to a non-

Interventional pursuant to Chapter 6. first subparagraph of paragraph 6 of the medicines Act 60



Decision on termination of a marketing authorisation in accordance with Chapter 6. section 10, second paragraph the medicines Act and termination of registration for sale 90



Decisions on the licensing of clinical trials according to Chapter 7. § 9 the medicines which do not include the examination of such medicinal products referred to in the fourth subparagraph 1 and 2 the same rule 60



Decisions on the licensing of clinical trials according to Chapter 7. § 9 the medicines act involving the testing of medicinal products referred to in the fourth paragraph (1) and (2) the same provision, however, does not review that refers to the xenogenic cell therapy 90



Decisions on the licensing of clinical trials according to Chapter 7. § 9 the medicines act involving xenogenic cell therapy no time limit



Decision on the authorisation of the manufacture of medicinal products and intermediate products as referred to in Chapter 8.

section 2 of the medicines Act, but not decisions relating to products covered by the hospitals except 90



Decision on the authorisation of the manufacture of products covered by the hospital exemption under Chapter 8. section 2 of the medicines Act 120



Decision amending such a manufacturing authorization referred to in Chapter 8. section 2 of the medicines Act 30, or if there are special reasons, 90



Decision authorising the importation of medicinal products and intermediate products as referred to in Chapter 9. section 1 of the medicines Act 90



Decision amending such permission to import referred to in Chapter 9. section 1 of the medicines Act 30, or if there are special reasons, 90



section 2 Of the FDA has requested that the applicant must complete an application, start the time-limits laid down in paragraph 1 to run only when the requested addition coming in to work. A deadline that the running of time shall be extended by the time that applicant need to come in with a supplement, unless the matter relates to consent to clinical drug trials in accordance with Chapter 7. § 9 the medicines Act (2015:315).



Provisions on deadlines for decisions is also available in Chapter 2.



Obligations under EU directives, section 3 of the FDA to perform the obligations to provide notifications or to otherwise disclose information or documents that the Member countries, the reference member States or competent authorities under



1. European Parliament and Council Directive 2001/83/EC, and



2. European Parliament and Council Directive 2001/82/EC.



The first paragraph is only valid data available to the Agency, within its area of operation.



The relationship to the public access to information and confidentiality disclosure according to EU directive



section 4 Disclosure under paragraph 3 or 3 Cape. 11 paragraph 1 and 2 shall take place even in case of data privacy concerns because according to publicity and secrecy (2009:400) to the extent that the Swedish medical products Agency's obligations means to send information to



1. the European Commission, 2. The European Medicines Agency, 3. Committee for medicinal products for human use at the European Medicines Agency,



4. The pharmacovigilance risk assessment by the European Medicines Agency, 5. The Committee for veterinary medicinal products at the European Medicines Agency, 6. Committee for herbal medicinal products in the European Medicines Agency, 7. authorities in another country within the EEA, 8. a coordination group referred to in article 27 of Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive 2010/84/EC, or article 31 of Directive 2001/82/EC, in wording pursuant to European Parliament and Council Directive 2004/28/EC, or 9. an international organization.



Chapter 8. Other provisions



Immunological veterinary medicinal products



section 1 the Agency may, after giving the State's agricultural work the opportunity to comment, prohibit the manufacture, import, possession, sale, supply or use of immunological veterinary medicinal products for

1. the use of the drug impedes the implementation of a national programme for the diagnosis, control and eradication of animal disease, or causes difficulties in determining the absence of any contamination in live animals or in foodstuffs or other products obtained from treated animals, or



2. the condition from which the medicinal product is intended to induce immunity to not at all present in Sweden or appear here only to a limited extent.



section 2 of the immunological veterinary medicinal products, at the point of entry referred to in Chapter 9. section 4 of the medicines Act (2015:315) only be introduced to Sweden from another country within the EEA where the conditions for authorisation in accordance with Chapter 5. paragraph 1 of the said law are met.



Supply and delivery of alcoholic medicines and technological liquor



paragraph 3 of The Decree of denaturation may only be for external use, disinfecting the instruments or laboratory use in the prescriber's professional activities.



If an alcoholic drug cannot be presumed to be capable of


abused in the intoxicating order, the FDA in the case may decide to derogate from Chapter 13. the first and second subparagraphs of paragraph 2 of the medicines Act (2015:315).



Requirement to be represented by counsel in some cases



section 4 of The who can request from the FDA, and is not resident in the EEA, shall be represented by an agent residing in this area.



Obligations of the competent authority in certain cases



paragraph 5 of the food and Drug Administration should carry out a competent government agency obligations under European Parliament and Council Regulation (EC) No 726/2004.



Certificate



section 6 of the Agency shall, upon request, issue a certificate 1. for permission to manufacture medicinal products, 2. for the export of medicines, or 3. for the export of certain batch of drugs.



Chapter 9. Appropriations Act Regulations on pharmaceutical applicability



section 1 the Agency may provide that the provisions of the medicines Act (2015:315) for authorization shall not apply in respect of certain medicinal products for veterinary use intended only for pets.



section 2 of the food and Drug Administration may, if necessary, from the health point of view, provide for the medicines Act (2015:315), except the provisions of Chapter 16 of the. in the Act, to apply in whole or in part, a product or group of products that are not medicines, but in terms of characteristics or usage is close to drugs.



Regulations on the requirements for and approval of drugs



section 3 of the FDA may provide for



1. exemption from the requirements of the full Declaration and clear labelling in Chapter 4. Article 1, second subparagraph the medicines Act (2015:315),



2. recognition of such approval or registration for the sale of a medicinal product which has been granted in another EEA country, and



3. application, preparation, approval or registration referred to in Chapter 4. section 9 of the medicines Act.



Regulations on medicines covered by hospital exception



section 4 of the food and drug administration, in respect of a medicinal product covered by a hospital except provide for



1. requirements for quality and safety monitoring, and



2. the conditions shall apply to the manufacture.



Regulations on specific medicines



paragraph 5 of the MPA may provide for what is meant by specific drugs.



Provisions on the obligation to provide data



section 6 of the MPA may provide that anyone who conducts business in health care and veterinarians to provide such information to the work required for the purposes referred to in Chapter 3. section 14.



Regulations on the manufacturing of drugs and management of medicines containing blood



section 7 of the MPA may provide for



1. manufacture and good manufacturing practice for medicinal products and intermediate products,



2. the manufacture, storage, distribution and import of blood and blood components intended to be used as raw material in the manufacture of medicinal products, and



3. imports of medicines containing blood or blood components.



Regulations on imports and other admission



section 8 of the FDA may provide about 1. exemption from the obligation to perform such a check referred to in Chapter 9. section 2 of the medicines Act (2015:315),



2. the traveller's right to bring the drugs into Sweden under Chapter 9. section 3 of the medicines Act,



3. the entry referred to in Chapter 9. section 4 of the medicines Act, and



4. exemption from the requirement for confirmation in writing in Chapter 9. 5 § 2 medicines Act in accordance with the provisions of Article 46b. 3 and 46b. 4 in European Parliament and Council Directive 2001/83/EC, in wording pursuant to European Parliament and Council directive 62/EU.



Regulations referred to in the first subparagraph 3 shall be notified only after the State's agricultural work were given the opportunity to comment.

Regulations on supply and supplying medicinal products and technological liquor



§ 9 the FDA may provide about 1. the disclosure, if there is reason to believe that an alcoholic pharmaceutical products other than those referred to in chapter 13.

paragraph 2(2) of the medicines Act (2015:315) can be abused in intoxicating order, 2. What should apply to the supply and delivery of a drug or alcohol, and 3. jurisdiction to order an alcoholic medicine containing more than 10% ethyl alcohol, or technological liquor.



section 10 of the Agency may, if necessary to prevent abuse, provide for the sale of a drug or alcoholic denaturation.



Additional regulations



section 11 of the food and Drug Administration may announce further provisions on matters relating to medicines Act (2015:315) and as necessary to protect human or animal health or the environment.



section 12 of the FDA may provide for the enforcement of the medicines Act (2015:315) and of this regulation.





Transitional provisions



2015:458



1. this Regulation shall enter into force on January 1, 2016.



2. The regulation repeals the drug regulation (2006:272).



3. The provision in Chapter 2. section 5 does not apply to those marketing authorisations have been granted, amended or renewed before 21 July 2012.