Data
section 1 the agency responsible for the control and supervision of
drugs, narcotics and some other products that
to properties or use are medications near and
oversight of medical devices, cosmetic products,
tattoo colours and some products intended for
cosmetic and hygiene purposes, to the extent such
issues should not be dealt with by another authority.
Regulation (2013:521).
2 §/expires U: 2016-01-01/
The FDA, in particular,
1. responsible for control and supervision under the medicines Act
(1992:859), the Act (1992:860) on the control of narcotic drugs,
European Parliament and Council Regulation (EC) No 273/2004 of the
on 11 February 2004 on drug precursors;
Regulation (EC) No 111/2005 of 22 december 2004 on the rules
for the monitoring of trade in drug precursors between the
community and third countries, the law (2009:366) on trade in
use and other regulations in the pharmaceutical sector in
the case of manufacturers, importers, distributors, retailers
and others who take positions with medicine,
2. responsible for supervision in the field of medical devices
under the Act (1993:584) concerning medical devices and
Act (2012:595) regarding the importation and trafficking of guns and
needles, and according to the rules given in
adherence to these laws,
3. responsible for control and enforcement in respect of certain products
as with respect to properties or use stands
medicine near,
4. responsible for supervision in the field of cosmetic products and
certain goods intended for cosmetic and hygiene
purposes,
5. respond to supervision in the case of tattoo colors,
6. responsible for regulations and general advice
medicines and other products that are subject to the Agency's
control or supervision,
7. participate in international cooperation in its
area of activity,
8. responding to the information within their area of responsibility to other
agencies and individuals,
9. responding to support the inspection for health and social care
supervisory activities as well as to the National Board of health and
The public health agency's contingency planning on
Pharmaceuticals,
10. responsible for research in areas of importance for the
control and oversight that the authority shall conduct,
11. perform the duties that a competent authority has, in accordance with
Council Regulation (EC) no 953/2003 of 26 May 2003 on the
avoid trade of certain key medicines
diversion into the European Union, as amended by Commission
Regulation (EC) No 1662/2005 of 11 October 2005
amending Annex I to Council Regulation (EC) no 953/2003
to avoid trade of certain key medicines
diversion into the European Union,
12. perform the duties that a competent authority has, in accordance with
European Parliament and Council Regulation (EC) No 2006/2004 of the
on 27 October 2004 on cooperation between national
authorities responsible for
consumer protection legislation, in regard to compliance with
such rules as the work has supervision over,
13. perform the duties that a competent authority has, in accordance with
articles 14 and 16(3) of the European Parliament and of the Council
Regulation (EC) no 816/2006 of 17 May 2006 on the
compulsory licensing of patents relating to the manufacture of
pharmaceutical products for export to countries with
public health problems,
14. arrange meetings where patient and consumer organizations
attending and, if necessary, enforcement officers, to
get information to the public about the prevention
operations and enforcement action taken to combat
the counterfeiting of medicines,
15. in its field work to the
generation targets for environmental performance and the environmental quality objectives
the Parliament has adopted and, where necessary, propose measures
development of environmental work,
16. provide producentobunden drug information
to the public,
17. by poison control center
a) provide poison information and treatment advice to health
health care and the public concerning acute poisonings with
drugs, chemicals and other products, and biological
toxins,
b) recommend and promote effective
antidotes,
(c)) to be the body referred to in article 13(6) of
European Parliament and Council Regulation (EC) no 1223/2009 of the
30 november 2009 on cosmetic products,
(d)) to be the body referred to in article 45 of the European Parliament's
and Council Regulation (EC) no 1272/2008 of 16 december
2008 on classification, labelling and packaging of substances and
mixtures, amending and repealing directives 67/548/EEC
and 1999/45/EC, and amending Regulation (EC) No 1907/2006,
18. conduct of investigation and development to
improve drug usage and promote coordination
and the interaction between the actors involved in this field,
19. within the framework of its own activities and in cooperation with
other actors working to contribute to the implementation of the
Sweden's policy for global development,
20. monitor and investigate the need for drugs explanation of
such goods constitute medicinal products or goods that have
potential medical uses,
21. discharge the functions required by the law (2011:111) if
destruction of certain harmful substances of abuse,
22. fulfilment of reporting obligations to International
Narcotics Control Board (INCB) in accordance with article 19, 20, 25
point 3 and article 27, point 2 of the 1961
Single Convention on narcotic drugs, article 16, paragraphs 4 to 6 of the 1971
Convention on psychotropic substances, and article 12 paragraph 12 of 1988
Convention against illicit traffic in narcotic drugs and
psychotropic substances (narcotics Crime Convention), and
23. on well secluded areas on its Web site provide only such
information, list and hyperlink referred to in article
85 c (4) of Directive 2001/83/EC of 6 november 2001 on the
Community code relating to medicinal products for human use, in
the wording according to European Parliament and Council directive
2011/62/EU, and such a hyperlink referred to in article 3 of
Commission implementing Regulation (EU) no 699/2014 of
24 June 2014 on the formulation of a common logo to
identify the people who offer distance marketing of
medicinal products to the public and about the technical, electronic
and cryptographic requirements to control the common
the logo's authenticity. Regulation (2015:203).
2 section/entry into force: 01/01/2016
The FDA, in particular,
1. responsible for control and supervision under the Act (1992:860) on the control of narcotic drugs, the European Parliament and Council Regulation (EC) No 273/2004 of 11 February 2004 on drug precursors, Council Regulation (EC) No 111/2005 of 22 december 2004 laying down rules for the monitoring of trade in drug precursors between the community and third countries, the law (2009:366) on trade in drugs, the medicines Act (2015:315) and other regulations in the pharmaceutical sector in terms of manufacturer , importers, distributors, retailers and others who take positions with drugs, 2. responsible for supervision in the field of medical devices under the Act (1993:584) concerning medical devices and the law (2012:595) regarding the importation and trafficking of syringes and needles, as well as according to the rules given in connection to these laws,
3. responsible for control and enforcement in respect of certain products which, because of their characteristics or usage are medicines near,
4. responsible for supervision in the field of cosmetic products and certain products intended for cosmetic and hygienic purposes,
5. respond to supervision in the case of tattoo colors,
6. responsible for regulations and general advice with regard to medicines and other products that are subject to the Authority's control or supervision,
7. participate in international cooperation in its field of activity,
8. responding to the information within their area of responsibility to other agencies and individuals,
9. responding to support the inspection for health and social care regulatory activities as well as to the National Board of health and the public health agency's contingency planning in the pharmaceutical sector,
10. responsible for research in areas of importance to the control and oversight that the authority shall conduct,
11. perform the duties that a competent authority has under Council Regulation (EC) no 953/2003 of 26 May 2003 to avoid trade diversion into the European Union essential medicines,
12. perform the duties as a competent authority under Regulation (EC) No 2006/2004 of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws, with regard to compliance with such rules as the work has supervision over,
13. perform the duties as a competent authority under articles 14 and 16(3) of Regulation (EC) no 816/2006 of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems,
14. arrange meetings where patient and consumer organisations and, if necessary, enforcement officers, in order to get information to the public about the prevention and enforcement measures taken to combat the counterfeiting of medicines,
15. in its field work for the generation targets for environmental performance and the environmental quality objectives which Parliament has determined is reached and, if necessary, propose measures for the development of the work environment,
16. provide producentobunden drug information to the public,
17. by poison control center
a) provide poison information and treatment advice to health care and the public concerning acute poisonings with drugs, chemicals and other products, and biological toxins,
b) recommend and promote effective antidotes,
(c)) to be the body referred to in article 13(6) of Regulation (EC) no 1223/2009 of 30 november 2009 on cosmetic products,
(d)) to be the body referred to in article 45 of Regulation (EC) no 1272/2008 of 16 december 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006,
18. conduct of investigation and development activities to improve drug usage and promote coordination and cooperation between the actors involved in this field,
19. within the framework of its own activities and in collaboration with other actors working to contribute to the implementation of Sweden's policy for global development,
20. monitor and investigate the need for drug Declaration of such goods constitute medicinal products or products which have potential medical use,
21. discharge the functions required by the law (2011:111) on the destruction of some hazardous substances of abuse,
22. fulfilment of reporting obligations to the International Narcotics Control Board (INCB) in accordance with article 19, 20, 25 point 3 and article 27, point 2, of the 1961 Single Convention on narcotic drugs, article 16, paragraphs 4 to 6 of the 1971 Convention on psychotropic substances, and article 12, paragraph 12, of the 1988 Convention against illicit traffic in narcotic drugs and psychotropic substances (narcotics Crime Convention), and 23. on well secluded areas on its Web site leave only such information, list and hyperlink referred to in article 85 c (4) of Directive 2001/83/EC of 6 november 2001 on the Community code relating to medicinal products for human use, in the wording pursuant to European Parliament and Council directive 62/EU, and such a hyperlink referred to in article 3 of Commission Regulation (EU) no 699/2014 by 24 June 2014 on the formulation of a common logo to identify the people who offer distance selling of medicinal products to the public and about the technical, electronic and cryptographic requirements for verifying the authenticity of the common logo. Regulation (2015:460).
section 3 of the food and Drug Administration may, within its area of responsibility and if
operations otherwise admits that perform assignments within or
outside the country. The missions to be performed for remuneration, corresponding to
the cost of such activities.
section 4 of the food and drug administration, concerned about their environmental efforts under
2 § 13 report to the environmental protection agency and consulting work
If the reporting is needed. Regulation (2011:85).
4 a of/expires U: 2016-01-01/
The FDA must periodically review the system for
security monitoring referred to in paragraph 9 of the medicines Act
(1992:859), in the part relating to pharmacovigilance system
of medicinal products for human use, and report the results every two years by the
the review of the European Commission.
Regulation (2012:348).
4 a section/entry into force: 01/01/2016
The FDA must periodically review the pharmacovigilance system referred to in Chapter 6. section 1 of the medicines Act (2015:315), in so far as the system relating to the pharmacovigilance of medicinal products for human use, and report the results of the examination every two years to the European Commission.
Regulation (2015:460).
4 b repealed by Regulation (2010:1642).
Collaboration
5 § the museums shall continuously consult consumer on
the areas where the authorities have a common
supervisory responsibilities.
The Agency's efforts to control knowledge should be scheduled
and be carried out in co-operation with other concerned authorities so that
the State management with knowledge regarding health and
health care is coordinated.
Provisions on cooperation with some other authorities see
Regulation (2015:155) if State control with knowledge
with respect to health care and social services.
Regulation (2015:165).
5 a § Authority announces their rules in Common
statutes relating to health care,
social services, medicine, public health, etc., in accordance with annex
1 to the Constitutional Assembly Ordinance (1976:725).
Regulation (2015:165).
Management
section 6 of the Authority is headed by a head of Government.
Regulation (2013:521).
section 7 at the Agency, there shall be an Advisory Council consisting
of not more than ten members. Regulation (2013:521).
Advisory bodies
7 a of The Authority is an advisory body linked, Council for
better use of medicines. The Council's mission is to assist
authority of its responsibilities in matters relating to an improved
use of medicines. Regulation (2010:417).
7 b of the Authority the Manager appoints members and is President of the
Council for better use of medicines.
Regulation (2010:417).
Positions and assignments
section 8, the Director General is the head of Government.
§ 9 the Director General decides on the employment of professors
at the MPA. When hiring professors applies
Chapter 4. 6 of the higher education Ordinance (1993:100) if
expert assessment. The experts shall be appointed after consultation with the
Uppsala University.
In terms of eligibility and assessment criteria when hiring
professors comes Chapter 4. 3 of the higher education Ordinance in
applicable parts. With high school means taking the MPA.
Regulation (2010:1778).
Staff disciplinary board
10 § at the Agency, there shall be a staff disciplinary board.
The applicability of specific regulation
section 11 of the staff representatives Ordinance (1987:1101) and
internal audit regulation (2006:1228) shall apply to
The medical products agency. Regulation (2011:1145).
Transitional provisions
2009:1096
1. this Regulation shall enter into force on december 27, 2009.
2. applications for admission under paragraph 4, permits
for sale under paragraph 5 of subsection 2. or purchase a permit
According to section 6 of the Act (1961:181) for the sale of denaturation
accommodation received by the Agency before the entry into force
but that has not yet been determined are dealt with under the older
regulations.
2012:348
1. this Regulation shall enter into force on 21 July 2012.
2. reporting to the European Commission should take place first
time last modified 21 september 2013.
