/Comes into force: 2016-07-01/

The scope of the law



section 1 of this Act apply to the processing of personal data for the purposes referred to in section 8 or 9 of the medical products agency and E-hälsomyndigheten in matters relating to licence applications for medicinal products, if the processing of personal data wholly or partially automated or if the data are or are intended to form part of a structured set of personal data which is available for searching or compilation according to specific criteria.



Definitions



section 2 of the licence referred to in this Act a licence pursuant to Chapter 4. paragraph 10(2) medicines Act (2015:315) for community pharmacies that sell drugs to satisfy the need for drugs for a particular patient, a particular animal or animals or livestock.



With community pharmacies within the meaning of this law, an establishment for the retail sale of medicinal products is carried out with authorization pursuant to Chapter 2. paragraph 1 of the law (2009:366) on trade in drugs.



Relation to other law



section 3 of this Act, the expressions that also occurs in the medicines Act (2015:315) has the same meaning as in the Act.



What this Act is provided in the case of medicinal products shall also apply to products and groups of products for which by virtue of chapter 18. section 2 of the medicines have been prescribed the medicines Act will apply, in whole or in part.



section 4 of the Swedish personal data Act (1998:204) applies to the Swedish medical products Agency's and E-hälsomyndighetens the processing of personal data in the activities relating to matters concerning licence applications for medicinal products, subject to the provisions of this Act or regulations issued in connection with this Act.



Demand for treatment



5 § personal data should be processed in such a way that the data subject's right to privacy is respected.



Documented personal information shall be handled and stored so that unauthorized persons do not have access to them.



The data subject's attitude to personal data treatment



section 6 of the processing of personal data is allowed under this law may be carried out even if the data subject is opposed to reading.



Privacy responsibility



section 7 of the medical products agency is personuppgiftsansvarigt for the Authority's personal data processing in respect of the application for the license.



E-hälsomyndigheten is responsible for the Authority's personal data processing in respect of the application for the license.



Purpose of personal data processing



paragraph 8 of the processing of personal data under this law if it is necessary to



1. Fda should be able to take decisions in the cases of application for license and retain data in such decisions,



2. The FDA under section 12 to be able to disclose information,



3. E-mail hälsomyndigheten to receive and preserve data in cases where the application for a licence,



4. E-hälsomyndigheten to bring together documents in cases where the application for a licence, and



5. E-hälsomyndigheten according to §§ 13-15 to disclose information.



9 § with regard to the processing of personal data for purposes other than those referred to in paragraph 8 of the terms of paragraph 9 (d), second subparagraph, the personal data Act (1998:204).



Search restriction



section 10 in the treatment of the personal data shall not be used as a reason for prescribing search terms.



Disclosure on medium for automatic processing



11 § gets a personal data disclosed may be done on medium for automatic processing.



Obligation to disclose information



section 12 of the FDA going to E-hälsomyndigheten disclose information in respect of the application for the license.



13 § E-hälsomyndigheten to the National Agency for medicines should disclose information in respect of the application for the license.



section 14 of the E-hälsomyndigheten to disclose information in respect of the application for a license to despatching staff at community pharmacies that require such information.



section 15 E-hälsomyndigheten to disclose information in respect of licence applications to the competent to order drugs and that have a need for such information.



Direct access



16 § Despatching staff in community pharmacies may, with the agreement of the search restriction imposed by section 10, to have direct access to such personal data in cases where the application for license to E-hälsomyndigheten that the staff of their business needs.



The competent to order medicinal products may, with the search restriction imposed by section 10, to have direct access to personal data in such cases, if the application for license to E-hälsomyndigheten containing personal data that he or she has provided to the Agency.



The patient may have direct access to personal information about himself in relation to the application for license to E-hälsomyndigheten.

Permission assignment



section 17 of The officer shall determine the conditions for the award of the permission for access to personal data which are processed automatically, in whole or in part. Jurisdiction should be limited to what is necessary for the working of the MPA or e-mail hälsomyndigheten to fulfil their duties.



Government or authority the Government determines may provide for the award of the permission for access to personal data which are processed automatically, in whole or in part.



Access control



section 18 of The officer shall ensure that access to personal information in whole or in part be processed automatically documented so that access can be checked after the event.

The officer will be systematic and periodic check if any unauthorized accessing such data.



Government or authority the Government determines may provide for documentation and control.



Thinning



section 19 personal information retained for screening of the MPA and E-hälsomyndigheten no later than 36 months after the Swedish medical products Agency's decision on the case.



Personal information submitted to E-hälsomyndigheten by someone who is competent to order medicinal products must, if data are not bundled together with an application for license, screen of E-hälsomyndigheten no later than 12 months after the data has been received by the authority.



Rectification and indemnity



section 20 of the provisions of the Swedish personal data Act (1998:204) correcting and damages shall apply in the case of the processing of personal data in accordance with this law.



Information



section 21 The officer shall ensure that the data subject of the personal data treatment.



The information should contain the following information:



1. who is responsible,



2. the purposes of the processing,



3. the obligation of law or regulation,



4. the privacy and security provisions applicable to information and treatment,



5. the right to take part of the information referred to in section 26 of the personal data Act (1998:204),



6. the right under section 20 to the correction of inaccurate or misleading information and to compensation in the treatment of personal data in contravention of this law,



7. what applies in the case of search restrictions, and



8. what applies in the case of thinning.