Chapter 1. The law's purpose and content
§ 1 the aim of this Bill is mainly to protect public and
animal life, health and well-being and to protect the
public health and protect the environment without this greater than
What is necessary, prevents the development of medicinal products or
trade in medicinal products in Sweden and within the European
economic area (EEA).
section 2 of the Act provides for
– expressed in the Act (Chapter 2),
– the scope of the Act (Chapter 3),
– requirements for medicines and the approval, registration and
permission for the sale of drugs (Chapter 4),
– requirements for the sale of drugs (Chapter 5.)
-security monitoring, control and withdrawal (Chapter 6),
– clinical drug trial (Chapter 7),
– manufacturing (Chapter 8),
-imports and other introduction (Chapter 9),
– precautionary requirements when handling drugs and active
substances (Chapter 10),
– time limits for decisions and the withdrawal of authorisations (11
Cape.)
– the marketing of medicines (12 chapters),
– supply and delivery of medicines and technological liquor
(13.),
– supervision (Chapter 14.)
– fees (Chapter 15),
– penalties and confiscation (Chapter 16);
– appeals (chapter 17), and
– appropriations (chapter 18).
The law also includes entry into force and
transitional provisions.
Chapter 2. Expression in law
section 1 of this Act, the following expression is used with the following
importance:
Active substance any substance or mixture of
substances that are intended to be used in
the manufacture of a drug and
which, when used for that purpose,
become an active component of the drug
which is intended to either have a
pharmacological, immunological or
metabolic action aimed at
restoring, correcting or modifying
physiological functions, or used
in order to make a diagnosis.
Alcoholic
medicine medicine containing more than 1.8
% of ethyl alcohol.
Extemporaneous drug preparations an establishment which has the national agency
permission to manufacture medicinal products for
a particular time.
Counterfeit medicines Each medicinal product with an error
Letter concerning its
– identity, including packaging and
mark, name or composition of
ingredients, including excipients,
and the strength of these constituents,
– origin, including manufacturers,
country of manufacture, country of origin,
marketing authorisation
sale, or
– history, including records and
documents from the use
distribution channels.
With falsified medicinal product "does not
medicinal products with an error
designation as a result of unintentional
quality defects.
Generic medicinal product which has the same qualitative and
quantitative composition in terms of
active substances and the same
pharmaceutical form as a
the reference medicinal product, and whose
bioequivalence with this
the reference medicinal product has been demonstrated by
appropriate bioavailability studies.
Different salts, esters, ethers, isomers,
mixture of isomers, complexes or
derivatives of an active substance shall be considered to
be the same active substance, unless they
do not differ significantly in properties with
for safety or efficacy.
Different pharmaceutical forms that are intended
to be ingested through the mouth and whose
drug substance immediately released
at the intake is considered to be the same
pharmaceutical form.
Help topic Each component of a drug
is not the active substance or
packaging material.
Medicinal Drugs for people.
Non-
intervention study
for safety A safety study of a
medicinal products for human use which is made after the
the drug is approved for sale
and initiated, implemented and
funded by the holder of the
approval and include the collection of
safety data from patients and
health-care professionals.
Clinical
drug trial a clinical examination on the people
or animals of a pharmaceutical
characteristics.
Drug any substance or combination of
substances that
– is presented as
has properties that prevent or
treat disease in humans, or
animals, or
– can be used on or administered
human beings or animals with a view to
restoring, correcting or modifying
physiological functions by
pharmacological, immunological or
metabolic action, or to set
diagnosis.
Drugs covered
of the Hospital except an advanced therapy medicinal product
as defined in article 2 of
European Parliament and Council
Regulation (EC) no 1394/2007 of 13
November 2007
advanced therapy medicinal products and amending
Directive 2001/83/EC and Regulation (EC)
No 726/2004, in the original
the wording, which
– produced in Sweden according to a
non-routine procedure,
– is a specialized product for a
individual patient in accordance with a
physician's prescription, and
– used in this country.
Intermediate product Processed substance, or mixture of
substances that are subject to
additional steps of
the manufacturing process of a
medicine, until the stage when
the product should be packaged in their
final packaging.
Investigational medicinal product A pharmaceutical form of an or
several active substances or placebo
being tested or used as a reference
in a clinical drug trial.
The term also encompasses products that
– have already been approved for sale
but used or manufactured in
other than the approved,
– used for a non-approved
indication, or
-used to get additional
information about an already approved
use.
Radiopharmaceutical drugs that emit ionising
radiation. Sealed sources are
not radiopharmaceuticals.
Technical alcohol has the same meaning as in Chapter 1. 4 §
alcohol Act (2010:1622).
Manufacturing Production, packaging or
repackaging of pharmaceutical products,
intermediates or active
substances.
Veterinary
medicinal products medicinal products including
premixtures for involvement in the feed.
Chapter 3. The scope of the law
section 1 of this Act only applies to medicinal products for human and
veterinary medicinal products which are intended to be placed
on the market in the EEA and prepared industrially
or by a method involving an industrial process. The law also applies to
denaturation.
Provisions concerning the importation from a country outside the EEA,
distribution and manufacturing also applies to medicinal products
only intended for export to a country not included in the
The EEA. These provisions also apply to intermediate products and
active ingredients and auxiliary substances intended for human use.
The law does not apply medicated.
Medicinal products authorised centrally within the European Union
2 § in the case of medicinal products for which marketing authorisation application
sales are, or have been tried in accordance with the
European Parliament and Council Regulation (EC) No 726/2004 of the
the Council 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, will not apply the provisions of 4
Cape. 2 and 6 to 9 section, paragraph 10 and 11-22 sections, Chapter 5. 1
paragraph 1 and 2 as well as the second and third paragraphs, 6
Cape. and chapter 18. 3 § 2-4.
In the case of medicinal products for which marketing authorisation
have been granted under the regulation does not apply
the provisions of Chapter 4. section 10, second paragraph, and Chapter 5. 1 §
first subparagraph 3.
Homeopathic medicines
section 3 For a homeopathic medicine that can be registered under
This law, the following provisions shall not apply to:
– Chapter 3. section 2, on medicinal products for which marketing authorisation application
for sale are, or have been tried in accordance with the
European Parliament and Council Regulation (EC) No 726/2004,
– Chapter 3. section 4, if the traditional herbal medicinal products,
— Chapter 4. section 1, if demands for drugs,
— Chapter 4. section 2 first, third and fourth paragraphs, if
marketing authorisation for medicinal products,
— Chapter 4. section 5, if registration for the sale of
traditional herbal medicinal products,
— Chapter 4. section 6, second paragraph, on the recognition of traditional
herbal medicinal products for human use,
— Chapter 4. the second subparagraph of paragraph 7, if certain immunological
medicines,
— Chapter 4. 12-16 sections, on certain questions regarding the approval of
the sale of medicinal products and data protection,
— Chapter 4. 18 paragraph 2 and article 19, if
information obligation,
— Chapter 4. 20-22 sections, relating to the classification, data protection and
interchangeability,
– Chapter 6. 1-4 and 8 sections, on pharmacovigilance and
control,
– Chapter 7, about clinical drug trial,
-12 Cape. Article 1, first and third subparagraphs, of the prohibition of
marketing,
-12 Cape. paragraph 3, on information function,
— Chapter 13. Article 1, first paragraph, for the appointment and disclosure
of medicine and engineering spirits, and
— Chapter 18. section 2, section 3, paragraph 1 and 4, with appropriations.
Traditional herbal medicinal products
4 section For a traditional herbal medicinal product may
registered under this law, the following provisions do not
apply:
– Chapter 3. section 2, on medicinal products for which marketing authorisation application
for sale are, or have been tried in accordance with the
European Parliament and Council Regulation (EC) No 726/2004,
– Chapter 3. section 3, if the homeopathic veterinary medicinal products,
— Chapter 4. the second to fourth paragraphs of section 2, concerning the approval of
the marketing of medicinal products,
— Chapter 4. section 4, if registration for the sale of homeopathic
medicines,
— Chapter 4. paragraph 7, concerning the recognition of a marketing authorisation for
veterinary medicinal products,
— Chapter 4. 13-15 sections, if the right to rely on documentation and if
data protection,
— Chapter 4. section 18, first paragraph, of the information obligation,
— Chapter 4. section 22, if interchangeability,
– Chapter 6. sections 6 and 7, for permission to
non-Interventional,
– Chapter 7, about clinical drug trial,
– Chapter 9 section 4, if the admission,
-12 Cape. Article 1, first and third subparagraphs, of the prohibition of
marketing, and
— Chapter 18. paragraphs 1 and 2 and paragraph 3 of 4, with appropriations.
As part of the Hospital except
section 5 For a medicinal product falling within the scope of the hospital exemption shall
the following provisions shall apply mutatis mutandis:
– Chapter 2. section 1 of the Act, if the expression
— Chapter 4. paragraphs 1 and 3, if the demand for drugs,
– Chapter 8. paragraphs 1 and 2, on the manufacturing,
-10 Cape. Article 1, first and third paragraphs, if
the precautionary requirements,
— Chapter 11. Article 1, first paragraph 11 and paragraph 2 of the first subparagraph, if the
time limits for decisions and the withdrawal of authorisations,
-12 Cape. section 1, banning the marketing,
— Chapter 13. Article 1, first paragraph, for the appointment and disclosure
of medicinal products,
— Chapter 14., on supervision,
— Chapter 15. 1, 3 and 4 sections, relating to fees,
-16 Cape. 1, 2 and 4 of section, regarding penalties and forfeiture,
— Chapter 17., on the appeal, and
— Chapter 18. 3 § 1, § 4 and § 8 2 and 10 to 12 sections, with
appropriations.
As provided in Chapter 6. § 1 in respect of medicines
approved for sale also applies to a medicine
covered by the hospital exemption.
The obligations set out in Chapter 6. 2 and 3 of which apply to the
that has been a drug approved for sale terms
even for those who have authorization to manufacture a pharmaceutical product
covered by the hospital exemption. The authority that the Government
determines, on a case by case basis, decide on derogations from these
obligations.
Drugs, doping substances and dangerous goods
section 6 of the provisions of this Act concerning narcotic drugs,
products covered by the Act (1991:1969) on the prohibition of the
some doping substances, or Act (1999:42) prohibiting certain
dangerous goods unless they are contrary to what is
legally required if these goods.
Product Safety Act
7 § in the case of medicinal products intended for consumers,
likely to be used by consumers also applies
the product safety Act (2004:451).
Chapter 4. Requirements for medicines and the approval, registration and
authorisation for the marketing of medicinal products
Requirements for medicines
1 §/expires U: 2016-04/12/
A medicine shall be of good quality and
effectively. The drug is appropriate if it is
effective for the purpose intended and in normal use is not
injurious effects which stands in the anomaly to the intended
the effect.
A drug should be fully declared, have sufficient
and the distinctive title and be provided with clear
labelling.
1 section/entry into force: 04/12/2016
A drug must be of good quality and fit for purpose. The drug is appropriate if it is effective for the purpose intended and in normal use do not have harmful effects that stand in the anomaly to the intended effect.
A drug should be fully declared, have sufficient and distinctive title and be provided with clear labelling. In the requirement for clear labelling is included in the case of a prescription-only medicinal products for human use, it shall be equipped with safety features. Law (2015:316).
Requirements for the approval, terms and some coordination
section 2 of a drug should be approved for sale on the
meets the requirements of section 1.
Decision concerning the authorisation of a medicinal product and authorisation to
sale under section 10 may be subject to special conditions.
Such special conditions for approval shall be reviewed annually
to the approval shall remain valid.
Have a drug approved in another EEA country, the application
If approval is rejected, if the applicant is not in the application requested that the
a recognition under section 6 or 7 shall be notified.
If an applicant at the time of the application for authorisation in
Sweden has submitted an application for authorisation in another
EEA country and the final decision is not given in the matter,
should the application be rejected in Sweden unless the claimant having
had the opportunity to this requested that proceedings under section 9
shall apply.
Requirements for products covered by the hospital exemption
3 § If a drug covered by hospital exception
contains a medical device referred to in section 2 of the Act
(1993:584) concerning medical devices, this product
meet the essential requirements referred to in regulations that have
notified pursuant to paragraph 6 of the same law.
The registration of homeopathic medicinal products
4 of a medicinal product manufactured in accordance with a recognized
homeopathic method, and which is not alleged to have some therapeutic
effect and that is intended to be ingested through the mouth or the intended
for external use shall, on application, be registered for sale,
If the degree of dilution ensures that the medicinal product is
harmless. It must be registered only if it does not
contains more than one ten-thousandth of the mother tincture or, in
the case of medicinal products for human use, more than one-hundredth of the lowest
use the dose of such active substance in drugs poses
It will be regarded as such.
A homeopathic veterinary medicinal product may
be registered irrespective of the manner in which it is given, if this
described in the European Pharmacopoeia nor in any other EEA
officially use the formulary.
The registration of traditional herbal medicinal products
§ 5 a herbal medicinal products that do not meet the requirements
to be approved as medicines, or to be registered under
section 4, on application, be registered for sale
traditional herbal medicinal products under this Act, if
the following conditions are true:
1. the product has only indications which are suitable for
traditional herbal medicinal products, whose
composition and purpose, are intended and designed to
be used without a doctor's diagnosis, prescription or monitoring
of the treatment,
2. the medicinal product may only administration in accordance with a specified strength and specific
dosage,
3. the product is intended to be ingested through the mouth or the intended
topical or inhalation,
4. the medicinal product or a product that corresponds to the product has
had medical uses for a period of at least 30 years
including at least 15 years in a country that at the time of application
are members of the EEA, and
5. There are sufficient data on the
traditional use and it is established that the vehicle is not
harmful when used at specified way and its
pharmacological effects or effects appear reasonable
on the basis of long-standing use and experience.
If a community herbal monograph is established, shall be taken into account.
In such cases, registration take place even if the requirements of the first
paragraph 4 are not fulfilled.
If it is necessary for the assessment of a traditional
herbal medicinal products safety, FDA
require an applicant to submit the results of the work of
clinical trials conducted in accordance with this
team.
Recognition of an authorisation or a registration of a
medicinal products given in another EEA country
section 6 of the approval or registration for the sale of
a medicinal product has been granted in another EEA country,
upon application, be recognized in Sweden, where there are no reasons to
assume that the drug might pose a serious
risk to public health.
In the case of a traditional herbal medicinal product for
can be registered under this law, the first subparagraph applies only
If a community herbal monograph has prepared over drug
or if it consists of materials or preparations which are
appearing on a list drawn up by the European
the Commission.
If the European Commission announced a decision in accordance with
Article 34(1) of the European Parliament and Council directive
2001/83/EC of 6 november 2001 on the
Community code relating to medicinal products, in wording as
European Parliament and Council Directive 2004/27/EC,
The MPA announce the decision resulting from the
the Commission's ruling. Equivalent should apply in the case
the Commission announced the decision in accordance with article 35(2) in
the directive, in the original wording.
Recognition of an authorisation or a registration of a
veterinary medicinal product granted in another
EEA country
section 7 an approval or registration for the sale of
a veterinary-medical drugs given in a
other EEA Member State shall, upon application, be recognized in Sweden, if it
There is no reason to believe that the drug could be
constitute a serious risk to human or animal health
or for the environment.
Approval of an immunological veterinary medicinal product
medicine should not be notified or be recognised:
1. the use of the drug has an effect on the implementation of the
a national programme for the diagnosis, control or eradication
of any animal disease or cause difficulties in
to establish that 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 is not at all present in Sweden or appear
This only to a limited extent.
If the European Commission announced a decision in accordance with
Article 38(1) of Directive
2001/82/EC of 6 november 2001 on the
Community code relating to veterinary medicinal products, in
the wording according to European Parliament and Council directive
2004/28/EC, FDA announce the decision
following the Commission's decision. Corresponding to the
cases, the Commission announced the decision in accordance with article 39(2)
or 40(1) of the directive, in the original wording.
The meaning of recognition
section 8 When recognition was decided according to paragraph 6 or 7
considered drug approved for sale in Sweden.
Have a homeopathic medicine or a traditional
herbal medicinal products that can be registered under this
teams registered in another EEA country and have registration
recognised in Sweden are considered drug registered for
sales in Sweden. The obligations of a
holders of an authorisation or a registration under
This law or regulations issued under the law
shall also apply to the holder of a recognition.
The decentralised procedure
section 9 If a drug is not approved for sale in any
EEA-country and application for authorization with
request for application of the decentralized procedure
referred to in Directive 2001/82/EC and
in European Parliament and Council Directive 2001/83/EC provided
in more than one country, the medical products agency, if
the applicant when applying in Sweden requested that Sweden works
as the reference Member State, manage the further preparation of the
application by preparing dossiers for other concerned
countries ' position on the drug. Corresponding to
apply to homeopathic medicinal products and traditional herbal
medicinal products that can be registered under this Act in the cases
the conditions in paragraph 6, second subparagraph, are met.
If the applicant has not requested that Sweden will act as
the reference Member State should, having regard to
Reference Member State basis, be approved or registered
in accordance with the conditions laid down for the recognition of
articles 6 and 7. Agency shall notify the decision
that follows the European Commission's decision, if
the Commission announced the decision in accordance with
1. Article 38(1) of Directive
2001/82/EC, in wording pursuant to European Parliament and Council
Directive 2004/28/EC, or
2. Article 34(1) of the European Parliament and Council directive
2001/83/EC, in wording pursuant to European Parliament and Council
Directive 2004/27/EC. Equivalent should apply in the case
the Commission announced the decision in accordance with article 39(2)
or 40(1) of Directive 2001/82/EC, in the original
the wording, or article 35(2) of Directive 2001/83/EC, in the
original wording.
Permission to use in the other cases
section 10 if there are special reasons, permission to
the sale of such a Center with funds not referred to
paragraph 4 of the left.
If there are special reasons, is authorized for sale
of a drug be submitted also in cases other than those referred to in 2,
4-7 and 9 sections.
Determining authority
section 11 of the FDA hears questions about the approval or
registration for sale under this Act.
The MPA also examines issues concerning the recognition of a
authorisation or registration has been issued in a
other EEA country.
The Government hears questions about permits for sale under
section 10. The Government must leave it to the FDA to examine
such questions.
The burden of proof and the competency requirements
section 12 of the applicant for approval, registration, or
permits for sale shall demonstrate that the requirements of paragraph 1 are
met. Documentation attached to the application shall have the
prepared by someone with sufficient expertise and
enough influence over the content of the documentation.
Some generic drugs
section 13 if, in an application for a marketing authorisation
relied on documentation for the reference medicinal product,
The FDA may allow the requirement on documentation in the form of
Preclinical studies and clinical trials fully
or partially met through the documentation for
the reference medicinal product, if the application refers to
1. a generic medicinal product, the reference medicinal product is or
has been authorised for not less than eight years in an EEA country or across
The EEA as a result of the decision of approval referred to in
European Parliament and Council Regulation (EC) No 726/2004,
or
2. a drug whose active ingredient or combination of
substances have the same therapeutic active ingredients
such a reference medicinal products referred to in 1.
In the case of veterinary medicinal products comes first
the paragraph also results from studies of the safety and
residue studies.
Data protection for certain documentation and terms of protection
section 14 a consent under section 13 may not be granted until
the time for data protection, as set out in this
clause, has expired.
MPA may, in the case of medicinal products for human use may allow a one-year
data protection when an application for a marketing authorisation
is made for a new indication for an already well-established substance,
provided extensive preclinical studies or clinical
trials of the new indication has been implemented.
The FDA may allow three years of data protection, in the case
an applicant has used scientific literature to
be granted a marketing authorisation for a medicinal product for a specific
animal species used for food production if the applicant, in
order to be granted approval for another species
used for food production, provided
1. new study of residues in foods in accordance with
European Parliament and Council Regulation (EC) no 470/2009 of the
6 May 2009 laying down Community procedures for the establishment
maximum residue levels for pharmacologically active substances in foodstuffs of animal
and repealing Council Regulation (EEC) no
2377/90 and amending European Parliament and Council directive
2001/82/EC of the European Parliament and Council Regulation (EC)
No 726/2004, and
2. new clinical drug trials for the same drugs.
15 § in cases where a drug approved for sale with
application of section 13, must the terms of protection specified in this
paragraph have expired from the original
authorisation for the reference product was granted before the
approved drug can be sold. The term of protection is 10 years, if
subject to the second to fourth paragraphs.
If the authorisation holder of the reference medicinal product as
is a medicinal product for human use in the first eight years of the
ten year period granted an authorisation for one or more
new therapeutic indications, which under the scientific
evaluation prior to approval is expected to result in a significant
higher medical benefits compared to existing
forms of treatment, the period may be extended to ten years
a maximum of 11 years.
The period of 10 years referred to in the first subparagraph shall be extended
for thirteen years for veterinary medicinal products intended for
fish or bees or other species determined in accordance
with the procedure referred to in article 89(2) a of the European Parliament and
Council Directive 2001/82/EC, in wording as
European Parliament and Council Regulation (EC) no 596/2009.
For such veterinary medicinal product which is intended
for animal species used for food production and as
contains a new active substance which, on 30 april 2004 even
was not approved in the EEA, the period of ten years referred to
in the first subparagraph may be extended by one year for each time
the authorisation should be extended to other animal species
used for food production, if it has been approved under
the five years immediately following the initial
the marketing authorisation was granted. This period shall
not, however, exceed a total of thirteen years in the case of a
authorisation holder relating to four or more
animal species used for food production. Extension
of this 10-year period to eleven, twelve or thirteen years of
a veterinary medicinal product intended for a species
used for food production should be granted only in
the condition that the holder of the marketing authorisation
also from the beginning has applied for the establishment of maximum
residue limits in food for the species covered by
the approval.
section 16 When a marketing authorisation has been granted for the
a drug, any additional strengths,
pharmaceutical forms, the ways in which it is given and
presentations, as well as any variations and extensions,
also be accepted or included in the original
the approval. These new approvals and the original
the approval shall for the purposes of section 13 and section 18 of the other
subparagraph are treated as the same approval.
The period of validity of the approval
section 17 of the authorisation is valid for five years and can
then be renewed. A renewal applies without
time limit, unless the Agency of
security reasons, finds that it should apply additional
a five-year period.
Application for renewal of an authorisation for a
1. the veterinary medicinal product shall be submitted to the
The FDA no later than six months before the marketing authorisation ceases
to apply, and
2. medicinal products for human use shall be submitted to the National Agency for medicines
at least nine months before the marketing authorisation ceases to be valid.
The approval comes in time for examination of an application for
renewal.
Information to the FDA and some lapse of
approval
section 18 of the one who has been a drug approved for sale
shall, for each approved variant of the drug, inform
The FDA about when it is released on the Swedish
the market. Anyone who has been a drug approved shall also
at least two months in advance, notify the FDA if
sales of the drug will be discontinued temporarily or
permanently on the Swedish market. If there are particular
reasons, the message is submitted more than two months in advance.
If the sale is for a medicinal product for human use, to the cause of
that sale ends indicated in the message. It should
particularly indicated for sale ends due to
1. the product is harmful,
2. the medicinal product lacks therapeutic efficacy,
3. the relationship between the benefits and risks of the medicinal product
changed,
4. qualitative and quantitative composition of the medicinal product
not as declared,
5. the methods of manufacture and control of the product is not
consistent with the reported,
6. an obligation relating to the grant of permission to
manufacturing has not been fulfilled, or
7. a condition of the marketing authorisation is not
been met.
Where medicinal products are not placed on the Swedish market in
three years of the authorisation was granted or, if
the term of protection of a reference medicinal product runs at the time
from the grant, from the drug was sold,
should FDA decide that approval should no longer be
apply. The same applies if a drug that previously
placed on the Swedish market during the three
the following years are not marketed in this country.
The medical products agency, with regard to the protection of public health
or animal health in the individual case may decide to derogate from
second paragraph.
section 19 of The patients who have received a medicinal product for human use authorised for
the sale shall, without delay, notify the FDA every
action taken to
1. suspend or no longer provide medicine,
2. request that the marketing authorisation is withdrawn, or
3. does not apply for renewal of the authorisation for sale.
In the message, the reasons for that action has been taken
specified. In particular, it must be specified if the measure has been taken to
as a result of the
1. the product is harmful,
2. the medicinal product lacks therapeutic efficacy,
3. the relationship between the benefits and risks of the medicinal product
changed,
4. qualitative and quantitative composition of the medicinal product
not as declared,
5. the methods of manufacture and control of the product is not
consistent with the reported,
6. an obligation relating to the grant of permission to
manufacturing has not been fulfilled, or
7. a condition of the marketing authorisation is not
been met.
If the measure has been taken as a result of something specified in
second subparagraph, 1-7, at the same time also the European
the Agency will be notified of the action. Anyone who has a
a medicinal product for human use authorised shall, without delay, also notify
The FDA and the European Medicines Agency on
the measure has been taken in a country outside the EEA, in cases
the measure has been taken as a result of anything referred to in the second
paragraph 1 – 7.
Classification of medicines
section 20 When a marketing authorization is issued, the
The FDA set if the medicinal product shall be classified as
prescription or over-the-counter medicines.
The FDA may also decide that a prescription
medicinal products shall be classified in other categories, with
limitations of what should apply to the supply and
disclosure of the drug.
If new facts relevant to the classification of
a medicine comes to the Swedish medical products Agency's knowledge or if
marketing authorisation applicants for amended
classification, should the FDA to reconsider and, where necessary,
change the classification of the medicinal product.
Data protection at the amended classification
section 21 If a change in the classification of a medicinal product for human use has
approved on the basis of significant pre-clinical tests or
clinical trials data protection for these
studies or trials for one year after the
original amendment was approved. Data protection means
such studies or trials may not be added to the basic
for a decision granting an application from another
applicant in another case if the amended classification or
approval of a drug that contains the same Active
substance or combination of substances.
Decisions on substitutability with regard to medicinal products
section 22 When a marketing authorisation has been granted,
The FDA decision on the drug is interchangeable with a
other medicine.
A medicine are interchangeable only to a product
which can be regarded as an equivalent product.
Provisions on the exchange of Drugs Act (2002:160)
If the pharmaceutical benefits, etc.
Chapter 5. Requirements for the sale of medicines
§ 1 A medicine must, unless otherwise specified in the third paragraph,
sold first then it
1. approved or registered in accordance with Chapter 4.
2, 4, 5 or section 9,
2. subject to recognition of an authorisation or a
registration for sale that has been issued in another
EEA country pursuant to Chapter 4. section 6 or 7, or
3. subject to the authorisation of the sale pursuant to Chapter 4. 10 §
second paragraph.
A Center with funds can be sold only after it covered
of permits for sale pursuant to Chapter 4. section 10 first
paragraph.
Medicines that are manufactured in a pharmacy for a particular patient, a
certain animals or livestock can be sold without
such approvals, registrations or recognition
referred to in the first subparagraph of paragraph 1 and 2.
section 2 of the Regulations on trade in drugs are available, except in
This law, in the law (2009:366) on trade in pharmaceuticals and in
Act (2009:730) on trade in some non-prescription medicines.
Chapter 6. Security monitoring, control and withdrawal
Pharmacovigilance system
section 1 the Agency shall be responsible for a system of
pharmacovigilance as a aims to collect,
record, store and evaluate scientific data on
suspected adverse reactions to medicinal products authorised for
sale.
The evaluation shall take into account in respect of medicinal products also
all available information which may have significance for
evaluation of the benefits and risks of the medicinal product as
terms of use which are not subject to the conditions set out in
the marketing authorisation holder, and in the case of side effects
associated with occupational exposure.
In the case of veterinary medicinal products must also be taken into account in all
available information relating to the lack of expected efficacy,
off-label use, investigations of the withdrawal period and risk
for damage or nuisance to the environment caused by
the use of the medicinal product and which may be relevant to the
evaluation of the benefits and risks of the drug.
section 2 of the one who has been a drug approved for sale
should have a pharmacovigilance system and follow
the development of the pharmaceutical sector and within the framework of the
approval to change the drug if necessary. Anyone who has a
a drug approved shall also, as part of
pharmacovigilance of the medicinal product, register, store,
evaluate and report information on suspicious
side effects of the drug in accordance with regulations
Government, or the Government authority determines,
communicate with support of Chapter 8. section 7 of the Constitution.
MAh is responsible for
processing operations of personal data that may be
be carried out in accordance with the first subparagraph.
section 3 of The who has been a drug approved for sale is
required to at his disposal an expert with
sufficient expertise who continuously responsible for
pharmacovigilance of the medicinal product. The expert shall be
living and working in the EEA.
Information on security risks
section 4 of the Information that the holder of a marketing authorisation for
the sale leaves the public about security risks at the
the use of a medicinal product shall be accounted for in an objective
way and must not be misleading. Such information shall
also be submitted to the FDA last in connection with
the public is informed.
If the information concerns a medicinal product, it shall at the same
date referred to in the first subparagraph shall also be submitted to the
The European Commission and the European
the Agency.
Non-Interventional
§ 5 a non-Interventional may not
be carried out if the study means that the use of the medicinal product
promoted.
If a non-Interventional has
carried out in Sweden, the marketing authorisation holder
sale send a final report to the agency within the
twelve months from the date of collection of the data referred to in
the first paragraph have been completed.
For the ethical review of research involving humans and
biological material from people contains provisions in the law
(2003:460) concerning the ethical review of research involving
humans.
section 6, If the marketing authorisation for a
medicinal products for human use is associated with a condition that a
non-Interventional safety shall be made,
the study, to be carried out in Sweden, only start when the
The FDA authorized it.
Agency shall give such permission if the study
1. does not require the use of the drug;
2. is designed in a way that corresponds to the purpose of the study,
and
3. is not such a clinical drug trial that requires
authorization by the FDA according to Chapter 7. § 9.
Major changes of the study may only be made with the permission
by the FDA.
The authority that the Government may, for studies
referred to in the first paragraph, in the individual case, provide for an exception
from the final report in paragraph 5 of the second paragraph.
paragraph 7 of the licence referred to in paragraph 6 of the first subparagraph may also
given by the pharmacovigilance risk assessment Committee
of medicinal products in the European Medicines Agency. Larger
changes of the study may only be made with the permission of the
the Committee. The marketing authorisation holder shall
submit a final report to the Committee within a period of 12 months from
the collection of the data has been completed.
Control and withdrawal
section 8 of the FDA must continuously check a
drugs that have been approved for sale and determine whether the
the approval should still apply. Agency may submit to the
receiving approval to show that the drug still
meet the requirements for approval.
§ 9 the FDA may decide that a person who has received a
medications approved for sale shall revoke the drug
from those holding it on
1. it is necessary to prevent injury,
2. the product is not effective for its purpose,
3. the product is not appropriate,
4. the product is not of good quality,
5. qualitative or quantitative composition of the medicinal product
not as declared, or
6. essential requirements in connection with the manufacture or import
are not met.
The recall has the same meaning as follows from paragraph 16 of the first
subparagraph, the product safety Act (2004:451).
section 10 of the food and Drug Administration may decide that a marketing
the sale should be suspended, changed or terminated
to apply if
1. on receiving a notice under section 8 can not show that
the drug still meets the requirements for the approval,
2. the conditions set out in the approval have not been followed,
3. a decision to withdraw the drugs have not been followed, or
4. the basic conditions for the approval of
other cases are no longer met.
At the request of the receiving a medicine approved to work
decide that the approval shall cease to be valid.
If a traditional herbal medicinal product for human use is no longer
meets the requirements for registration on the ground that a
herbal substance, preparation or a combination of
These have been excluded from the list referred to in article
16F. 1 of European Parliament and Council Directive 2001/83/EC, in
the wording according to European Parliament and Council directive
2004/24/EC, the holder of the registration be able
within three months from the date on which the holder obtained the part of
an order completion from the medical products agency, to
Agency submitting the particulars and documents required
to show that the drug can be registered on any other basis.
Chapter 7. Clinical drug trial
Performance of clinical trials
§ 1 A clinical drug trial may be conducted to investigate the
the extent to which a drug is appropriate. The clinical
pharmaceutical examination may be carried out in connection with
disease treatment or without such a link. A clinical
drug testing may be carried out on people only by a
licensed physician, or a licensed dentist and on
animals only by a licensed veterinarian. The performing
the trial should have sufficient expertise in the field
the trial concerns.
For clinical trials on humans are also
provisions in the Act (SFS 2003:460) concerning the ethical review of research
involving humans. For clinical trials on animals
There are provisions in the animal welfare Act (1988:534).
Information for volunteers
section 2 of The patients or subjects referred to participate in a
clinical trials should receive such information if
the trial that they can consider whether they want to participate in
it. They shall also be informed of their right to
cancel their participation.
If the patient or the subject is a minor or a
person whose meaning cannot be obtained due to illness,
mental disturbance, weakened health or something else
similar relationship, this information should be submitted to the
people whose consent to participation in the trial should
be obtained under paragraph 3 of the second or third paragraph. In addition, the
the patient or subject, as far as possible, be informed
personally on trial. If he or she is a minor, the
the information is provided by professionals with educational experience.
Consent
3 § consent to participation in clinical drug trial
always be obtained. Consent shall, unless otherwise provided by other
or, third, obtained from the patients or
subjects referred to participate in the trial or, at
test to be performed on animals, from the animal owner.
In the case of minors, should consent be obtained from
the guardians. The minor's attitude should
is possible be clarified. Although the guardians have consented
the trial must not be performed if the minor understands
what the trial brings to his or her part and
oppose it is performed.
When it comes to people whose meaning cannot be obtained on
because of illness, mental disorder, weakened health conditions
or any other similar relationship to consent
from the trustee or custodian under Chapter 11. 4 or 7 §
parental code with permission to ensure the individual's
person. Consent shall be obtained from the patient's nearest
relatives. Consent shall express the patient's presumed wishes.
Even if consent to trial has been obtained, it should not
be performed if the patient in any form gives expression to not
like to participate.
Withdrawal of consent
paragraph 4 of the consent to participation in clinical drug trial
may at any time be withdrawn with immediate effect. The
information that originates in prior to that, however, may be used in
trial. A withdrawal agreement shall not affect the
continued care of the patient or
the subject.
Prohibition of certain clinical trials
5 § Clinical drug trial that is not related to
disease treatment may not be carried out on those who receive care
under the Act (1991:1128) on involuntary psychiatric or
Act (1991:1129) on forensic psychiatric care.
Clinical trials on minors
6 § clinical drug trial may, unless section 5 applies,
be performed on minors only if
1. the research is expected to lead to the direct benefit of this
patient group,
2. the research is essential to validate data
obtained in clinical trials with people who have
ability to consent to participation in clinical trials or through
other research methods,
3. the research directly relates to a clinical condition from which the
minor suffers or is of such a nature that it can only be
be carried out on minors, and
4. no incentives or financial inducements are given with
except for expenses.
Clinical trials on people whose meaning cannot be
be obtained
7 § clinical drug trial may be conducted on the meaning
cannot be obtained due to illness, mental disorder,
a weakened state of health, or any other similar
relation only if
1. the research is essential to validate data
obtained in clinical trials with people who have
ability to consent to participation in clinical trials or through
other research methods,
2. the research directly relates to a life-threatening or debilitating
clinical condition from which the person concerned is suffering from,
3. There are grounds for expecting that administering the
medicinal product to be tested benefit that outweighs the risk associated
for the patient or does not involve any risks at all, and
4. no incentives or financial inducements are given with
except for expenses.
Free investigational medicinal products and equipment
section 8 in order to conduct a clinical drug trial
It is assumed that the person, company, institution or
the organization responsible for initiating, organizing and
possibly finance the trial free of charge
provides patients and subjects
investigational medicinal product and, where appropriate, the equipment
required to use it.
The requirement for free does not apply to clinical
drug trial
1. is carried out without the participation of the pharmaceutical industry,
2. relating to orphan medicinal product for which marketing authorisation
together with conditions for follow-up studies, or
3. is of particular importance for public health.
Permission for clinical trials
§ 9 A clinical drug trial may only be implemented since
permission to trial has been issued or deemed to be granted
According to the third paragraph. Questions about permit review by
The medical products agency.
If the FDA finds that permission cannot be granted,
the applicant shall be informed accordingly. The applicant may, if only
an opportunity to change the content of the application in order to remedy the
deficiencies the FDA found. If the application does not change
should it be rejected.
If the Agency has not taken a decision within 60 days from
It came in a complete application to the Office, the
authorisation shall be deemed to have granted in accordance with the application.
The third subparagraph shall not apply in the case of an application for authorisation to
implementing a clinical drug trial involving
1. tissue engineered products, as well as gene therapy and
somatic cell therapy including xenogenic cell therapy
2. medicinal products containing genetically modified
organisms,
3. medicinal products which are not authorised in accordance with
European Parliament and Council Directive 2001/83/EC, which
covered by the annex to the European Parliament and of the Council
Regulation (EC) No 726/2004, the wording under
European Parliament and Council Regulation (EC) no 1394/2007,
or
4. drug whose active ingredient or ingredients are
a biological product derived from human or animal
or contains biological components derived from
human or animal or whose production requires such
components.
Chapter 8. Manufacturing
Requirements for manufacturing
section 1 the Manufacture must take place in purpose-built premises and carried out
using the appropriate equipment and otherwise be in
accordance with good manufacturing practice. An expert with
sufficient expertise and sufficient influence to ensure
to the requirements of the medicines and mellanprodukternas quality and
security requirements are met.
Extemporaneous drug preparations, for the manufacture of pharmaceutical products for a
given the opportunity to be manned by one or more
pharmacists.
Requirements for authorisation
section 2 of the Professional manufacture of medicinal products and intermediate products
as well as the manufacture of products covered by the
Hospital exception may be carried out only by the person who has
The Swedish medical products Agency's permission.
Manufacture of medicines for a particular time on
outpatient pharmacy or hospital pharmacy requires permission only
When the manufacture refers to products covered by the
Hospital exception. For mechanical single dose distribution on
community pharmacies are, however, provisions relating to authorisation
in Chapter 6. Act (2009:366) on trade in drugs.
Requirements for licence holders
3 §/expires U: 2016-04/12/
Those who have been granted an authorisation pursuant to article 2 of the
the manufacture of medicinal products for human use shall
1. by making use only active substances
manufactured in accordance with good manufacturing practice and
distributed in accordance with good distribution practices for active
substances,
2. immediately notify the FDA and the holder of the
the marketing authorisation for the medicinal product for
the licensee is informed that a drug that
covered by the manufacturing authorisation is, or is suspected
be, a counterfeit drug,
3. check that the manufacturer, importer or
distributors from whom licensee acquired the active
substances are registered with the FDA as 10 Cape.
section 2 or of the competent authority within the EEA,
4. check the active substances and excipients
authenticity and quality, and
5. ensure that the ingredients are suitable for use in
medicine, apply good manufacturing practice for help topics and
document actions.
3 section/entry into force: 04/12/2016
Those who have been granted an authorisation pursuant to article 2 of the manufacture of medicinal products for human use shall
1. by making use only active substances as manufactured in accordance with good manufacturing practice and distributed in accordance with good distribution practice for active substances,
2. immediately notify the FDA and the holder of the marketing authorisation of the medicinal product if the licensee is informed that a drug covered by the manufacturing authorisation is, or is suspected to be, a counterfeit drug,
3. make sure that the manufacturers, importers or distributors from whom licensee acquired the active substances are registered with the FDA as 10 Cape.
section 2 or of the competent authority within the EEA,
4. check the active substances and excipients authenticity and quality,
5. ensure that the ingredients are suitable for use in medicine, apply good manufacturing practice for help topics and document the actions, and
6. check the security features of the medicinal products for which the holder of the handling. Law (2015:316).
Chapter 9. Import and other admission
Authorisation for importation from a country outside the EEA
1 § Drugs or intermediate products may be imported from a
the only country outside of the EEA who are authorised to
the manufacture of medicinal products or special permission to
import of medicines.
Agency may decide if special permission to
imports of medicinal products within the meaning of the first subparagraph of
1. medicinal products imported to meet needs of
drugs that can be sold on the basis of a licence pursuant to Chapter 4.
section 10, second paragraph,
2. medicinal products to be used for other purposes than medical care,
or
3. an investigational medicinal product.
Of 3 and 4 sections shows that travellers and veterinarian in
some cases have the right to bring the drugs into the country.
Requirements for special
section 2 of the import medicinal products or intermediate products from
a country outside the EEA on the basis of a licence to manufacture
should hire an expert with adequate competence and
enough influence to be responsible for checking that the
each batch of drugs that come from a
third-country nationals, whether manufacturing has taken place in the EEA, the
undergone a complete qualitative analysis in an EEA country, a
quantitative analysis of all the active substances and all
other tests or checks necessary to
ensure the quality in accordance with the requirements
on the basis of the marketing authorisation.
Travellers ' right to bring in medicines
3 § travellers may bring in medicine in Sweden, if they are
intended for medical purposes and the travellers ' personal
use.
Importation for veterinary use
section 4 of the Vets who would otherwise serving in another EEA country,
from such a country to Sweden bring daily requirement of
veterinary medicinal products, even if the conditions for
in accordance with Chapter 5. paragraph 1 are not met.
Import of active substances intended for human use
§ 5 active substances intended for human use,
imported from a country outside the EEA only if they
1. is manufactured in accordance with standards that are
good manufacturing practice at least equivalent to, and
2. be accompanied by a written confirmation by a competent
authority of the exporting country, which shows that good
manufacturing practices have been followed.
10 Cape. Precautions when handling drugs and
active substances
section 1 of The professional manufacture, import, sell,
transporting, storing or otherwise professional
handling agents should take the actions and otherwise comply with the
such caution is needed to prevent drugs
harm people, property or the environment, and ensure that
the quality does not deteriorate.
Radiopharmaceuticals may be prepared only in hospitals and
pharmacies and may only be used in hospitals, if not
The MPA of the case admits something else.
The that in cases other than professional managing agents should
take the steps and observe the precautions in other
needed to prevent drugs harm people,
property or the environment.
section 2 of The professional manufacture, import or
deploy active substances intended for medicinal products for human use shall
the National Agency for medicines
1. notify its activities no later than 60 days before the business
begins,
2. report annually to changes in relation to the
notifications under 1, and
3. immediately report changes in operations that can
affect the quality or safety of the active substances
as the operator handle.
If the agency within 60 days after the work has
receipt of a notification referred to in the first subparagraph 1 has decided
to conduct an inspection, may not be initiated
before the FDA decided that it must be done.
paragraph 3 of the Distribution of active substances intended for
medicinal products for human use shall be in accordance with good distribution practices.
11 kap. Provisions on time limits for decisions and
revocation of authorization
Certain time limits
section 1 of the Government, with the support of Chapter 8. section 7 of the Constitution
announce regulations that specify the time within which such decisions
referred to in the following decisions:
1. Chapter 4. paragraph 2, for a marketing authorisation for medicinal products,
2. Chapter 4. paragraph 4, concerning the registration of sale of
homeopathic medicinal products,
3. Chapter 4. paragraph 5 of the first paragraph, if registration for sale
of traditional herbal medicinal products,
4. Chapter 4. paragraph 6, on the recognition of an authorisation or a
registration for the sale of a medicinal product for human use,
5. Chapter 4. section 7, the recognition of an authorisation or a
registration of the marketingauthorisation fora
medicines,
6. Chapter 4. section 9, second paragraph, of the decentralised
procedure when Sweden is not the reference Member State,
7. Chapter 4. section 10, for a licence to sell in the other cases,
8. Chapter 6. section 6 of the first subparagraph, where a
non-Interventional,
9. Chapter 6. section 10, second paragraph, of the termination of authorisation
for sale at the request of the Administration
approved,
10. Chapter 7. section 9, for permission to clinical
drug trial,
11. Chapter 8. section 2, on the licensing of professional manufacture of
medicinal products and intermediate products, and
12. Chapter 9. paragraph 1, for the import of medicines and intermediates
from a country outside the EEA.
Withdrawal of some State
section 2 of a State pursuant to Chapter 4. section 10, Chapter 7. section 9 first
paragraph, Chapter 8. 2 section or Chapter 9. Article 1, first subparagraph,
be revoked if any of the essential conditions which were
fulfilled when the State was issued are no longer fulfilled
or if any of the requirements which are of particular importance to quality
and safety have not been respected.
An authorisation shall be deemed granted under Chapter 7. § 9 third
subparagraph may be withdrawn if the conditions set out in the application for authorisation
are no longer fulfilled, or if any of the requirements of
particular importance to quality and safety have not been
been followed.
12 Cape. Advertising of medicinal products
Prohibition on marketing
section 1 of the Marketing of medicinal products for human use which have not been approved
for sale is prohibited.
Advertising of medicinal products for human use should not be addressed to children.
With the exception of campaigns for the vaccination of people against
infectious diseases are marketing of prescription
drugs that are directed to the public is prohibited.
Advertising of medicinal products for human use
section 2 of the Marketing of medicinal products for human use should promote a
proper use of the product by a presentation
that is up to date, factual and balanced. Marketing takes
not be misleading and shall also otherwise be
compliance with good practice for such marketing.
Such advertising for medicinal products for human use which is targeted at the general public
must be designed so that it is clear that the message is
an advertisement and that the product is a medicine. The contents of the
such advertising may not be designed so that it can lead to
the use of drugs that cause injury or otherwise
way is not effective or that people do not
looking for relevant care.
In respect of the marketing of medicinal products for human use, such
information that is of particular importance for the general public
and for people who are authorized to order or
supply medicinal products. In respect of the marketing of homeopathic
medicines registered may, however, only such information
to be indicated on the packaging and the package leaflet should be used. In
marketing for registered traditional herbal
medicinal products for human use shall indicate that the product is a registered
traditional herbal medicinal product for use in
some indication or certain indications and
indications which are subject to registration is based
exclusively on the experience of long-term use.
The Government or the authority that the Government can
with the support of Chapter 8. section 7 of the Constitution provide
on the advertising of medicinal products for human use.
Information function
section 3 of The who has been a drug approved for sale
should have a feature with scientific expertise who oversees
information about the medicine.
Chapter 13. Supply and delivery of medicines and technical
Liquor
§ 1 the person who appoints or giving out medicines, especially
comply with the requirements for expert and diligent care and on
information and consultation of the patient or representative
for the latter.
Such information about a medicine that has particular relevance
to prevent injury or to promote an effective
use must be made in writing when the medicine
is provided to a user.
section 2 of An alcoholic products may be released only from
Pharmacy.
A pharmacy may disclose technical spirits or alcoholic
medicinal products containing more than 10% ethyl alcohol
only
1. in the recipe or other order of the competent
to order technical liquor or drugs, or
2. to another pharmacy.
The first and second subparagraphs shall not apply to such retail
referred to in Chapter 4. 1 paragraph Act (2009:366) about
trade in medicinal products.
The Government or the authority that the Government may
If an alcoholic drug cannot be presumed to be capable of
abused in the intoxicating order, in each case decide
If exceptions to the first and second subparagraphs.
section 3 of The drug or alcoholic denaturation may not
disclosure if there is particular reason to assume that the goods
is intended to be used in the intoxicating effect.
4 section About health care disciplinary board in accordance with Chapter 8. 10
or section 11 of the patient safety Act (2010:659) has limited
or drawn in a doctor's or a dentist's credentials
to prescribe a drug, alcoholic denaturation
or other specific medicines than narcotic drugs,
such medicines or denaturation of the appointment of
your doctor or dentist is not left out. The same applies when
Disciplinary Board of animal health has suspended
a veterinarian or limited authority to prescribe a
alcoholic drug or denaturation.
Chapter 14. Supervision
section 1 the Agency has oversight over compliance with
1. this Act and the regulations and conditions which have been notified to the
with the support of the law,
2. European Parliament and Council Regulation (EC) No 726/2004
and regulations and conditions that have been notified under
the regulation,
3. European Parliament and Council Regulation (EC) no 1901/2006
of 12 december 2006 on medicinal products for paediatric
use and amending Regulation (EEC) No 1768/92,
Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC)
No 726/2004 as well as the rules and conditions that have been notified to the
with the support of regulation and
4. European Parliament and Council Regulation (EC) no
1394/2007.
section 2 of the food and Drug Administration has the right to request the
information and documents needed for supervision.
FDA oversight has right of access, on the one hand
for areas, buildings and other facilities used in
associated with the production or other processing of drugs,
of active substances, excipients, or by
packaging materials for pharmaceutical products, as well as areas where
review of pharmaceutical characteristics is carried out. The medical products agency
may conduct research in such areas and take samples. For
the outlet sample is not paid compensation. The FDA has
though not under this Act is entitled to access to the
housing.
On request, the person in possession of such goods as referred to in
second paragraph, provide the necessary assistance in the investigation.
section 3 of the FDA must notify the injunctions and prohibitions
required for compliance with this Act and the
regulations, rules and conditions under section 1 of the
within the scope of supervision.
Decision on the injunction or prohibition may be subject to a penalty.
Refused entry or help get the FDA also
submit to the penalty.
15. Fees
Application fee
§ 1 application fee to be paid by the applicant for
1. approval or registration for the sale of a
medicines,
2. recognition of such approval or such
registration for the sale of a medicinal product which has
in another EEA country,
3. authorization for sale pursuant to Chapter 4. section 10 other
subparagraph,
4. licence for manufacture of medicinal products,
5. such adjustments of the marketing authorisation for a
medicinal product or a registration for the sale of a
traditional herbal medicinal products that cause
the indications for the drug extended, or
6. authorisation to perform a clinical drug trial.
Additional fee
Article 2 of the Additional fee must be paid by the
1. register or apply for other changes in the conditions of
an authorisation or a registration for sales than
those referred to in paragraph 5,
2. demands that Sweden acts as reference Member State under
Chapter 4. § 9, first subparagraph, or
3. Requests that the agency draws up or supplement a
assessment report in connection with an application in a different
EEA country on the recognition of an approved or in Sweden
registered medicines.
Annual fee
paragraph 3 of the annual fee shall be paid as long as an approval, a
registration or a licence referred to in paragraph 1 applies.
Annual fee may also be charged for funds that have been authorized
for sale pursuant to Chapter 4. section 10 of the first paragraph.
Special fee
section 4 of the special levy shall be payable by the scientific
counseling agency in connection with the development of
a medicine.
Special fee shall also be paid by the person on request
a certificate by the FDA for permission to manufacture
drugs or for the export of drugs or certain
batch of drugs.
16. Penalties and forfeiture
§ 1 the person who wilfully or negligently contravenes article
3.1, 12.2 or 37(2) of the European Parliament and of the Council
Regulation (EC) No 726/2004, in the original wording,
or Chapter 5. Article 1, first and second subparagraphs, Chapter 7. § 9
first paragraph, Chapter 8. section 2, Chapter 9. Article 1, first subparagraph, or
10 Cape. section 1 of this Act shall be liable to a fine or imprisonment
a maximum of one year, if the Act is not subject to punishment according to the
the criminal code or under the Act (2000:1225) of punishment for
smuggling.
In minor cases, it should not be responsible.
section 2 of the pretend to be competent to order
drugs to get a drug delivered in violation of what
as is prescribed, shall be liable to a fine if the Act is not
faced with stricter penalties under the criminal code or
Patient Safety Act (2010:659).
The same applies to the who in such intention invokes a recipe
from an unauthorized person.
section 3 of The leaving out an alcoholic drugs, technical
alcohol or another particular drugs than narcotic
drugs in violation of the provisions of Chapter 13. 2, 3 or
4 section or regulations issued pursuant to chapter 18. section 8
1 or 3 or section 9, shall be liable to a fine. The same applies to the
improperly take action with an alcoholic drugs,
not intended for internal use, in order to make the product
useful for ingestion.
4 of A medicinal product which has been subject to offences under this
law or the value of it and the exchange of such breach,
be declared forfeited, unless it is manifestly unfair.
Chapter 17. Appeal
paragraph 1 of the Decision that the FDA announced in an individual case
under this Act, or pursuant to a precept has been issued
with the support of the law may be appealed to the General
Administrative Court.
Leave to appeal is required for an appeal to
the administrative court.
section 2 of the FDA decision, the administrative court or
the Administrative Court in a particular case, announces effective immediately,
unless otherwise decided.
Chapter 18. Appropriations
Regulations on the law's applicability
section 1 of the Government or the authority, as the Government determines
may provide that the provisions of this law concerning
marketing authorisation shall not apply in the case of certain
veterinary medicinal products intended solely for
pet.
section 2 of the Government or the authority, as the Government determines
may, if necessary, from the health point of view, please let
regulations on the law, but the provisions in Chapter 16,
in whole or in part shall apply to an article or group of goods that do not
are drugs but in terms of properties or the use is
near medicine.
Regulations on the requirements for and approval of drugs
3 §/expires U: 2016-04/12/
The Government or the authority, as the Government determines
may provide for
1. exemption from the requirements of the full Declaration and clear
labelling in Chapter 4. paragraph 1, second subparagraph,
2. recognition of such approval or such
registration for the sale of a medicinal product which has
in another EEA country,
3. application, preparation, approval or registration
referred to in Chapter 4. section 9, and
4. conditions for the interchangeability of medicinal products.
3 section/entry into force: 04/12/2016
The Government or the authority that the Government may provide for
1. that the requirement for security details in Chapter 4. paragraph 1 shall also apply to some non-prescription medicinal products,
2. exemption from the requirements of the full declaration, clear labelling and security details in Chapter 4. paragraph 1, second subparagraph,
3. verification of the safety features referred to in Chapter 4. paragraph 1, second subparagraph,
4. recognition of such approval or registration granted in another EEA country,
5. the application, preparation, approval or registration referred to in Chapter 4. section 9, and
6. conditions of interchangeability of medicinal products.
Law (2015:316).
Regulations on medicines covered by hospital exception
section 4 of the Government or the authority, as the Government determines
may, in respect of a medicinal product covered by hospital exception
provide for
1. requirements for quality and safety monitoring, and
2. the conditions shall apply to the manufacture.
Regulations on the manufacturing of drugs and the handling of
medicines containing blood
section 5 of the Government or the authority, as the Government determines
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
the manufacture of medicinal products, and
3. imports of medicines containing blood or
blood components.
Regulations on imports and other admission
section 6 of the Government may provide for the
conditions that apply to that State shall be
granted under Chapter 9. Article 1, second paragraph.
section 7 of the Government or the authority, as the Government determines
may provide for
1. exemption from the obligation to perform such a check that
referred to in Chapter 9. section 2,
2. the traveller's right to bring the drugs into Sweden under 9
Cape. section 3,
3. the entry referred to in Chapter 9. paragraph 4, and
4. exemption from the requirement for confirmation in writing in Chapter 9. paragraph 5 of the
2 in accordance with Article 46b. 3 and 46b. 4 in European Parliament
and Council Directive 2001/83/EC, in wording as
European Parliament and Council directive 62/EU.
Regulations on supply and supplying medicinal products and
technological liquor
section 8 Government or authority the Government determines
may provide for
1. disclosure, if there is reason to believe that a
alcoholic pharmaceutical products other than those referred to in chapter 13.
section 2 of the second paragraph can be abused in intoxicating order,
2. what should apply to the supply and delivery of a
medicines or denaturation, and
3. permission to order an alcoholic medicines
contains more than 10% ethyl alcohol, or technological
spirits.
§ 9 the Government or authority the Government determines
may, if necessary to prevent abuse, please notify
regulations on the sale of an alcoholic drug
or denaturation.
Rules relating to fees
section 10 of the Government may provide for the size of the
fees provided for in chapter 15. and on payment of such
fees.
Regulations on drug control in war
section 11 of the Government may provide for
drug control in wars at the war danger or in such
extraordinary circumstances are caused by war or by
danger of war that remained in Sweden.
Additional regulations
section 12 of the Government or the authority, as the Government determines
may announce further provisions on matters relating to this
law and as necessary to protect human or animal
health or the environment.
Transitional provisions
2015:315
1. this law shall enter into force on the 1 January 2016.
2. By the Act repeals the medicines Act (1992:859).
3. The authorisation of medicinal products granted
before 1 May 2006, at the end of the period for
the approval will be renewed indefinitely, if not
The FDA, for safety reasons, finds that the renewed
the authorisation should be limited to five years.
4. What the Act States should apply in the case of medicinal products for
the application for authorization has been tried
According to European Parliament and Council 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 as well as on
establishing a European Medicines Agency, shall, in
applicable, also apply in respect of a medicinal product in respect of which
the application for authorisation has been examined by the European Community
According to Council Regulation (EEC) No 2309/93 of 22 July 1993
laying down Community procedures for the authorisation
and supervision of medicinal products for human and veterinary
use and establishing a European
pharmaceutical authority.
5. The terms of protection provided for in Chapter 4. section 13 and section 15
the second to fourth paragraphs shall not apply in respect of
reference medicinal products for which an application for approval submitted
prior to October 30, 2005. For veterinary
medicinal products, rather than the terms of protection shall be applied as follows
Article 13 of the European Parliament and Council directive
2001/82/EC of 6 november 2001 on the
Community code relating to veterinary medicinal products, in its
amended before 30 april 2004. For medicinal products for human use shall, in
place the terms of protection apply pursuant to article 10(1) of the
European Parliament and Council Directive 2001/83/EC of 6
November 2001 on the Community code relating to
medicinal products, as amended before 30 april 2004.
6. where the application for authorisation of clinical trials
made before 1 May 2004, as regards the provisions on
the trial which was in force prior to that date.
7. the provisions of Chapter 6. 5 – 7 sections do not apply to such
non-interventional studies on safety initiated
before 21 July 2012.
2016:132
The Government states that the Act (2015:316) amending the medicines Act (2015:315) shall enter into force on 12 april 2016. The provisions on security details for the first time three years after the Commission delegated Regulation (EU) no 2016/161 of 2 October 2015 on the completion of a European Parliament and Council Directive 2001/83/EC by establishing detailed rules concerning the security details as indicated on the packaging of medicinal products for human use has been published in the official journal.