Pharmaceutical Law (2015:315)

Original Language Title: Läkemedelslag (2015:315)

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2015:315

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.