EU – sturcture of legal
provision
Title
The complete title of an act comprises:
• the type of act
• the number, the year and the sequential number of the act,
• the name of the author of the act,
• the date of adoption
• the subject matter
Preamble
Preamble - citations
Citations indicate:
the legal basis for the act:(a)
• primary acts that constitute the general basis for the text in question.
• Primary acts are cited without a footnote reference. International
agreements and protocols to international agreements may be cited
in their short form with a footnote reference.
• where applicable, secondary acts that constitute the specific basis for
the text.
Preamble - recitals
set out the reasons for the contents of the enacting terms (i.e. the
articles) of an act.
• Recitals are introduced by the word ‘Whereas:’.
• They are numbered and each sentence in each recital starts with a
capital letter and ends with a full stop, except the last sentence of the
concluding recital, which ends with a comma.
Articles
• The enacting terms, which constitute the normative part of the act, are divided into articles.
• Articles may be grouped in ‘parts’, ‘titles’, ‘chapters’ and ‘sections’
• Articles may be subdivided into paragraphs, subparagraphs, points, indents and sentences.
• Paragraphs may be unnumbered or numbered with Arabic numerals and may contain points
or indents, which may be preceded by a dash.
NB:
In French, numbered paragraphs are termed ‘paragraphe’ and unnumbered paragraphs are
termed ‘alinéa’.)
Final article (in directives and decisions)
• the addressees are specified in this last article.
Compulsory character of regulations
• In regulations, after the final article, the following formula is used:
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
Concluding formulas
Place, date and signature
• The act ends with the following:
• followed by the signature(s).
• In treaties, international agreements, etc. the full date is written in
words
Annexes
• rules or technical data that - frequently take the form of a list or table
in annexes
• The enacting terms must always indicate clearly, by means of a
reference
• In annexes, any appropriate system of numbering or subdivision may
be used.
Rules on drafting documents
• Acts published in the Official Journal follow strict drafting rules.
• Texts for publication in the Official Journal must exist in each of
the official languages of the European Union
• When published, the texts in all language versions of the Official
Journal are synoptic, meaning that the same text can be found on the
same page of the same OJ in all official languages.
Amendments
• 1. Where a whole article is replaced, the new text starts with the
designation of the article:
• Regulation (EC) No XX/20ZZ is amended as follows:
(1)
in Article 3, point (g) is replaced by the following:‘(g)
“state of processing” means the way the fish is preserved (fresh, fresh
salted and frozen).’;
Amendments
• if a sentence is being replaced, no subdivision marker is repeated,
even if the first sentence of a numbered paragraph is subject to an
amendment:
in paragraph 4, the first sentence is replaced by the following:
Czech legal system
Week 7+8, part I
Czech Republic
• The Czech Republic is one of the two successor states established
in 1993
• Since 1 st May 2004, the Czech Republic is a member of the
European Union
Czech Republic
• The political system is recognised as a
parliamentary democracy
Czech legal system
• The Czech legal system is a “continental” legal system
• more specifically, due to common historical roots, it can be
said it belongs to the “Germanic” legal culture.
The state power
• divided into the classical three powers, namely:
• Legislature = the Parliament of the Czech Republic
• Executive = the head of state and the government
• Judiciary = the courts of general jurisdiction (civil and criminal),
administrative courts and the Constitutional Court.
• There are also self-governing units
The Legislative Power in CZE
• is vested in the Parliament
• The Parliament - two chambers:
the Lower House: Chamber of Deputies ( Poslanecká sněmovna )
the Upper House: Senate ( Senát )
• The Chamber of Deputies:
• 200 members who are elected every 4 years
• The renewal of the Chamber is always complete
The Legislative Power in CZE
The Senate:
• 81 senators, who are elected to a six-year term of office
• partial renewal of the Senate every 2 years
• The Senate has a stabilising role in the constitutional system.
• Eg.: if the Chamber of Deputies is dissolved the Senate is empowered
to adopt legislative measures on matters which cannot be delayed
The Executive power
shared between:
• the President of the Republic and the Government.
• the President of the Republic - directly elected. The functions of the
head of state - mostly representative
The Government
• highest body of executive power
• consists of:
the Prime Minister,
deputy prime ministers
ministers
• The government is politically responsible to the Chamber of
Deputies
Ministries
• The Ministry of Finance
• The Ministry of Health
• The Ministry of Education, Youth
and Sports
• The Ministry of Foreign Affairs
• The Ministry of Culture
• The Ministry of Labour and Social
Affairs
• The Ministry of Justice
• The Ministry of Interior
• The Ministry of Industry and Trade
• The Ministry for Regional
Development
• The Ministry of Agriculture
• The Ministry of Defence
• The Ministry of Transport
• The Ministry of Environment
Ministries
• The ministers are appointed by the President of the Republic
upon the proposal of the Prime Minister
• The President of the Republic will also recall a minister if the
Prime Minister so proposes
The Judiciary
• The judiciary in the Czech Republic is defined by the Constitution so
that the courts perform their duties as independent authoritie.
• The system of ordinary courts is made up of District, Regional, High
courts and the Supreme
• General (civil and criminal), administrative and constitutional
judiciary.
The Public Defender of Rights
• The office of the Public Defender of Rights (the Ombudsman) has
been established by the law: Act no. 349/1999 Coll., the Public
Defender of Rights)
• He/she is elected by the Chamber of Deputies for a term of 6 years
The Public Defender of Rights
• His/her task is to defend individuals against such conduct of
authorities that does not comply with principles of a democratic
state, rule of law and good administration, as well as against illegal
inactivity of those authorities
• In order to protect public interest he/she has the special legitimation
to challenge a decision of an administrative authority at an
administrative court…
Idea of separation of powers
• The legislature, the head of state and most of the
executives:
located in the capital.
• Both Supreme courts and the Constitutional Court:
• located in Brno.
• Brno is also the seat of the Public Defender of Rights -
Ombudsman.
Central agencies of state administration under governmental
control
• There are a considerable number of other central
agencies, that perform necessary administrative tasks.
• These agencies - enjoy a certain degree of
independence of government.
•
Self-Government
There are two types of self-government in the Czech
Republic:
•territorial
•professional
Chambers
• typically exercise regulatory and disciplinary powers vis-à-vis its
members
• membership is being the precondition for the the respective
regulated profession.
• (establishment … by law…)
Czech legal system
• Only written law is recognised as a formal source of law.
• … judgments… = Judikáty
Czech legal system
The characteristics:
• Principle areas of law and procedures are codified
• (Civil and Criminal Codes, Administrative Procedure etc.);
Sources of law
• The legal order is assorted in a pyramidal-type structure:
• The lower levels of the pyramid have to be compatible with the
higher ones.
• Constitution and constitutional laws
(including the Charter of Fundamental Rights and Freedoms)
• International treaties
• Statutes adopted by the Parliament
• Derived legislation and legislative acts of territorial self-governing
units
Since the Czech Republic’s accession to the European Union:
• EU law and its legislative sources
part of the Czech legal order...
Who can adopt a legislative act?
• The Parliament
• The government, ministries or authorities of state administration;
• Self-governing units within the delegated competence
• Self-governing units within the independent self-governing
competence
Constitutional statutes
• are legislative acts of the highest legal force.
• passed by a special majority being necessary in both Chambers of Parliament
and with the agreement of both chambers
• The most important constitutional laws are:
• Constitutional law no. 1/1993 Coll., the Constitution of the Czech
Republic
• Resolution no. 2/1993 Coll. of the Presidium of the Czech National
Council of 16 December 1992 on the declaration of the Charter of
Fundamental Rights and Basic Freedoms as a part of the constitutional
order of the Czech Republic
• …
Czech legal system
• The Constitution of the Czech Republic founded on respect for rights
and freedoms of a man and citizen
• An important part of the Constitution and constitutional order is the
Charter of Fundamental Rights and Freedoms
• Albeit being in a separate constitutional law, it has the same legal
force as the Constitution itself.
International treaties
• Priority over ordinary statutes
Ordinary statutes -Act
• The universal form of legislative decision making adopted by the
Parliament.
• Published in the Collection of Laws of the Czech Republic:
• Collection of laws (Coll) ( Sbírka zákonů , abbreviated in Czech as “Sb.” )
Ordinary statutes
the standard form of citation is:
“number of the document” / ”year of the publication” Coll.
The number of every document is unique.
• The document number 1/1993 Coll. thus refers to the first document
published in the Collection of laws in the year 1993
Senate’s legislative measure
• special type of legislation with the force of statute
Governmental order
• is a form of legislation adopted by the government
• legal force is lower than the force of a statute
• purpose is to implement a statute (derived legislation)
Regulations
• Decree
• other principal form of secondary derived legislation
• adopted by ministries and other administrative agencies (central,
regional and local) or bodies of territorial self-governing units.
• regulations can be adopted only upon an express empowerment
contained in the respective law.
• stay within the bounds of the law .
Generally binding ordinances
• adopted by territorial self-governing units within their self-governing
competence
• a form of secondary legislation
• must comply with ordinary and constitutional statutes.
Types of legal norms in CZE - conclusion
• Following are the types of the generally binding legal regulations applicable in the CZE
• EU regulations, directives , decisions (published in the Official Journey of the
European Union)
• international treaties (published in the Collection of International Treaties of
the Czech Republic),
• laws, government orders and regulations (published in the Collection of Laws of
the Czech Republic),
• regulations issued by regional and municipal authorities (published in the regions’
journals of legal enactments, Collection of Legal Enactments of the
Capital City of Prague, on official information boards of municipal
authorities),
• some other instruments referred to by legal enactments…
Relations between legal norms, adopting of
legal norms - conclusion
• international treaty over national legislation
• EU directives and regulations enjoy the same status as international
treaties
• law must not contradict CZE Constitution and the Charter of Human
Rights and Freedoms
----------------------------------------------------------------
• laws are adopted by the CR Parliament
• regulations and government orders are not adopted by Parliament;
they are issued by relevant ministries or the government
Promulgation and publication of the legislation
• to be valid: it must be duly promulgated
• act in the Collection of laws (Coll) – Czech language only
• International - Collection of International Treaties, where the authoritative foreign
version, as well as the Czech version, is published simultaneously.
• The publication in the Collection of International Treaties ( Sbírka mezinárodních smluv ,
abbreviated in Czech as “Sb.m.s.” ) follows the same numbering principles.
Collections
• Both Collections are published in a printed version by the Ministry of
Interior.
• They are also fully accessible online in a “PDF” format from 1945
onwards at the Ministry of Interior web page
• The only authentic version of Czech legislation is in the Czech
language.
Law – valid/comes into force…
• A law is valid from the day it is published in the Collection of
Laws.
• The day when a law comes into force is usually specified by
the text of the law itself.
Law amendments
• Laws can later be amended.
• Such amendments are also published in the Collection of Laws and
are also allocated a number.
• Amendments include information on which part of the law is being
amended, as well as on how and when this change takes effect.
• Changes only are published with the amendment, not the entire
modified text of the original law!
Structure
• Number/Year Coll, Name:
• Hypothesis
• Disposition
• Sanction
• Repealing provisions
• Legal Force/Effect (date)
• annex
The overview of legal regulations governing
pharmaceuticals/pharamacy practice in the EU
• Directive 2001/83/EC of the European Parliament and of the Council
of 6 November 2001 on the Community code relating to medicinal
products for human use
• In force
• Commission Directive 2005/28/EC of 8 April 2005 laying down
principles and detailed guidelines for good clinical practice as regards
investigational medicinal products for human use, as well as the
requirements for authorisation of the manufacturing or importation
of such products
• In force
• Commission Directive 2003/94/EC of 8 October 2003 laying down the
principles and guidelines of good manufacturing practice in respect
of medicinal products for human use and investigational medicinal
products for human use
• In force
• Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003
setting standards of quality and safety for the collection, testing, processing, storage and
distribution of human blood and blood components and amending Directive 2001/83/EC
• In force
• Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of
the European Parliament and of the Council as regards certain technical requirements for
blood and blood components
• In force
• Commission Directive 2005/62/EC of 30 September 2005 implementing Directive
2002/98/EC of the European Parliament and of the Council as regards Community
standards and specifications relating to a quality system for blood establishments
• In force
• Directive 2004/9/EC of the European Parliament and of the Council of
11 February 2004 on the inspection and verification of good
laboratory practice
In force
• Directive 2004/10/EC of the European Parliament and of the Council
of 11 February 2004 on the harmonisation of laws, regulations and
administrative provisions relating to the application of the principles
of good laboratory practice and the verification of their applications
for tests on chemical substances
• In force
• Directive 2001/18/EC of the European Parliament and of the Council
of 12 March 2001 on the deliberate release into the environment of
genetically modified organisms and repealing Council Directive
90/220/EEC - Commission Declaration
In force
• Directive 2010/84/EU of the European Parliament and of the Council
of 15 December 2010 amending, as regards pharmacovigilance,
Directive 2001/83/EC on the Community code relating to medicinal
products for human use
In force
• Directive 2012/26/EU of the European Parliament and of the Council
of 25 October 2012 amending Directive 2001/83/EC as regards
pharmacovigilance
In force
• Directive 2005/29/EC of the European Parliament and of the Council of
11 May 2005 concerning unfair business-to-consumer commercial
practices in the internal market and amending Council Directive
84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the
European Parliament and of the Council and Regulation (EC) No
2006/2004 of the European Parliament and of the Council (‘Unfair
Commercial Practices Directive’)
• In force
• Directive 2011/24/EU of the European Parliament and of the Council
of 9 March 2011 on the application of patients’ rights in cross-border
healthcare
• In force
• Commission Implementing Directive 2012/52/EU of 20 December
2012 laying down measures to facilitate the recognition of medical
prescriptions issued in another Member State
• In force
• Directive 2011/62/EU of the European Parliament and of the Council
of 8 June 2011 amending Directive 2001/83/EC on the Community
code relating to medicinal products for human use, as regards the
prevention of the entry into the legal supply chain of falsified
medicinal products
• In force
• Commission Delegated Regulation (EU) 2016/161 of 2 October 2015
supplementing Directive 2001/83/EC of the European Parliament and
of the Council by laying down detailed rules for the safety features
appearing on the packaging of medicinal products for human use
• In force
• Commission Directive 2005/61/EC of 30 September 2005
implementing Directive 2002/98/EC of the European Parliament and
of the Council as regards traceability requirements and notification of
serious adverse reactions and events
• In force
• Directive 2001/20/EC of the European Parliament and of the Council
of 4 April 2001 on the approximation of the laws, regulations and
administrative provisions of the Member States relating to the
implementation of good clinical practice in the conduct of clinical
trials on medicinal products for human use
• No longer in force
• Directive 2009/35/EC of the European Parliament and of the Council
of 23 April 2009 on the colouring matters which may be added to
medicinal products (recast)
In force
• others
• Regulation (EC) No 726/2004 of the European Parliament and of 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
• In force
• Commission Regulation (EC) No 1234/2008 of 24 November 2008
concerning the examination of variations to the terms of marketing
authorisations for medicinal products for human use and veterinary
medicinal products
• In force
• Regulation (EC) No 1901/2006 of the European Parliament and of the
Council 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
• In force
• Regulation (EC) No 141/2000 of the European Parliament and of the
Council of 16 December 1999 on orphan medicinal products
• In force
• Regulation (EC) No 1394/2007 of the European Parliament and of the
Council of 13 November 2007 on advanced therapy medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No
726/2004
• In force
• Regulation (EU) 2016/793 of the European Parliament and of the Council of
11 May 2016 to avoid trade diversion into the European Union of certain key
medicines
• In force
• Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down
the provisions for implementation of the criteria for designation of a
medicinal product as an orphan medicinal product and definitions of the
concepts 'similar medicinal product' and 'clinical superiority'
• In force
• Commission Implementing Regulation (EU) No 520/2012 of 19 June
2012 on the performance of pharmacovigilance activities provided
for in Regulation (EC) No 726/2004 of the European Parliament and of
the Council and Directive 2001/83/EC of the European Parliament and
of the Council
• In force
• Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the
arrangements for reporting suspected unexpected adverse reactions which
are not serious, whether arising in the Community or in a third country, to
medicinal products for human or veterinary use authorized in accordance
with the provisions of Council Regulation (EEC) No 2309/93
• In force
• Regulation (EU) No 536/2014 of the European Parliament and of the Council
of 16 April 2014 on clinical trials on medicinal products for human use, and
repealing Directive 2001/20/EC
• In force
• Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on
the detailed arrangements for the good clinical practice inspection
procedures pursuant to Regulation (EU) No 536/2014 of the European
Parliament and of the Council
• In force
• Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014
supplementing Directive 2001/83/EC of the European Parliament and of the
Council with regard to principles and guidelines of good manufacturing
practice for active substances for medicinal products for human use
• In force
• Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February
2004 on drug precursors
• In force
• Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the
monitoring of trade between the Community and third countries in drug precursors
• In force
• Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing
Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug
precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring
of trade between the Union and third countries in drug precursors, and repealing
Commission Regulation (EC) No 1277/2005
• In force
• International treaties:
• Single convention on Narcotic drugs
• Convention on Psychotropic substances
• Commission Delegated Regulation (EU) No 357/2014 of 3 February
2014 supplementing Directive 2001/83/EC of the European
Parliament and of the Council and Regulation (EC) No 726/2004 of the
European Parliament and of the Council as regards situations in which
post-authorisation efficacy studies may be required
• In force
• Directive 2001/104/EC of the European Parliament and of the Council
of 7 December 2001 amending Council Directive 93/42/EEC
concerning medical devices
• Directive 98/79/EC of the European Parliament and of the Council of
27 October 1998 on in vitro diagnostic medical devices
• In force
• Directive 2000/70/EC of the European Parliament and of the Council
of 16 November 2000 amending Council Directive 93/42/EEC as
regards medical devices incorporating stable derivates of human
blood or human plasma
• Directive 2007/47/EC of the European Parliament and of the Council
of 5 September 2007 amending Council Directive 90/385/EEC on the
approximation of the laws of the Member States relating to active
implantable medical devices, Council Directive 93/42/EEC concerning
medical devices and Directive 98/8/EC concerning the placing of
biocidal products on the marke
• Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices
• Commission Regulation (EU) No 207/2012 of 9 March 2012 on
electronic instructions for use of medical devices
• Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5 April 2017 on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 90/385/EEC and
93/42/EEC
• Regulation (EU) 2017/746 of the European Parliament and of the
Council of 5 April 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Directive 2001/83/EC ( 32001L0083) of the European
Parliament and of the Council on the Community code relating
to medicinal products for human use
Week 7 +8 part III
Directive 2001/83/EC
• Aim:
rules governing the production, distribution and use of medicinal
products must be to safeguard public health
Directive 2001/83/EC
• The aim attained by means which will not hinder the development of
the pharmaceutical industry or trade in medicinal products
Directive 2001/83/EC
• approximation of the relevant national provisions
Directive 2001/83/EC
• Documents which must accompany an application for marketing
authorization for a MP:
demonstrate that potential risks are outweighed by the therapeutic
efficacy of the product.
Directive 2001/83/EC
• The adoption of the same standards and protocols by all the Member
States
Directive 2001/83/EC
• Committee for Proprietary Medicinal Products - to EMA
Directive 2001/83/EC
Announced:
necessary to adopt specific provisions for:
• immunological medicinal products,
• homeopathic medicinal products,
• radiopharmaceuticals,
• medicinal products based on human blood or human plasma
Directive 2001/83/EC
• necessary to exercise control over the entire chain of distribution of
MP,
• to guarantee products are stored, transported and handled in suitable
conditions
• To combat with counterfeit MP
Directive 2001/83/EC
• Pharmacists should be exempt from obtaining special
authorization/licence.
• But: keep records showing transactions in products
Directive 2001/83/EC
• Rules should be laid down as to how the labelling and package
leaflets are to be presented •
high degree of consumer protection
Directive 2001/83/EC
• Medicinal product
• Substance:
• Active substance:
• Excipient:
Directive 2001/83/EC
• Adverse reaction: A response to a medicinal product which is noxious
and unintended.
• Serious adverse reaction: An AR which results in death, is lifethreatening,
requires inpatient hospitalisation or prolongation of
existing hospitalisation, results in persistent or significant disability or
incapacity, or is a congenital anomaly/birth defect.
• Unexpected adverse reaction: An AR, the nature, severity or outcome
of which is not consistent with theSmPC.
Directive 2001/83/EC
• Abuse of medicinal products: Persistent or sporadic, intentional
excessive use of medicinal products which is accompanied by harmful
physical or psychological effets
• Medicinal Prescription: Any medicinal prescription issued by a
professional person qualified to do so.
• Name of the medicinal product:
• Common name:
• Strength of the medicinal product:
• Immediate packaging/Outer packaging
• Labelling:
• PIL
• Pharmacovigilance system:
• Herbs
• Falsified
• shall apply to MP for human use intended to be placed on the market
in MS and either prepared industrially or manufactured by a method
involving an industrial process
• not apply to
• PLACING ON THE MARKET
Marketing authorization
No medicinal product may be placed on the market of a Member State
unless a marketing authorisation has been issued by the competent
authorities
• Marketing authorization
• The application shall be accompanied by the documents, see Annex
• reference medicinal product
• generic medicinal product
• Procedures relevant to the marketing authorization
• Mutual recognition and decentralised procedure
• particulars at least appear on packagings
laid down requirements
• Name MP, name of the holder of the authorisation, expiry date, batch,
• method of administration,
• contents by weight, by volume or by unit
• easily legible, clearly comprehensible and indelible.
• Braille format
• authenticity and identification
• ...this medicinal product is subject to additional monitoring..
• CLASSIFICATION OF MEDICINAL PRODUCTS
Holders of distribution authorization
• minimum requirements:…
• Equipment, personell,…
• they must verify that the medicinal products received are not falsified
by checking the safety features on the outer packaging, in accordance
with the requirements laid down in….
• SALE AT A DISTANCE TO THE PUBLIC
• advertising of medicinal products
• Article 86
• the general public,
• persons qualified to prescribe or supply them,
• medical sales representatives
• supply of samples,
Advertising
• shall encourage the rational use of the medicinal product, by
presenting it objectively and without exaggerating its properties,
• shall not be misleading.
• Member States shall prohibit any advertising of a medicinal product
in respect of which a marketing authorization has not been granted in
accordance with Community law.
• The end:
• GENERAL PROVISIONS and
• FINAL PROVISIONS
• Member States shall take all appropriate measures to ensure that the competent
authorities concerned communicate to each other such information as is appropriate
• Directives – repealed
• enter into force
• Whom is addressed
CZE legal regulations governing
pharmaceuticals, health care services
Week 7 +8 part IV
Act No. 378/2007 Coll., on Pharmaceuticals, as
amended
• This Act incorporates the relevant legal provisions of the EU, with a view to
directly applicable regulations of the EU:
a) the research, manufacture, preparation, distribution, control, and
elimination of MP and active substances
b) the marketing authorisation, post‐marketing surveillance, prescribing and
supply of MP, sale of selected medicinal products, and the provision of
information;
c) international cooperation in the assurance of public health protection and
the development of a uniform market of MP in the EU;
d) record‐keeping on the activities listed…
General Provisions
Definition: What is?
• Medicinal product
• Substance: active substance, excipient
• Summary of the Product Characteristics
• Pharmacovigilance
• ADR
• ADE
General Provisions
Definition: What is?
• The name of a medicinal product
• Strength of the medicinal product
• Package leaflet
• Handling of pharmaceuticals
• Distribution of pharmaceuticals
• Dispensing of medicinal products
• The use x Abuse of medicinal products x Off‐label use
• Counterfeit medicinal product
• ……
• (pre‐mix for medicatedfeeding stuffs, medicated feedingstuff, Withdrawal period)
General Provisions
Definition: What is?
• The provider
• GMP
• GDP
• GPP
• Use of medicinal products in the delivery of healthcare services and
veterinary care
• Tasks of authorities performing state administration in the field of
pharmaceuticals
SIDC/ Institute for State Control of Veterinary Biologicals and Medicine
• Qualification of persons handling pharmaceuticals - General
prerequisites, Professional prerequisites
• MARKETING AUTHORISATION OF MEDICINAL PRODUCTS AND ISSUES
RELATED
• medicinal product may not be placed on the market in the Czech Republic,
unless it has been:
• a) authorised by the Institute, where a human medicinal product is
concerned, or by the Veterinary Institute where a veterinary medicinal
product is concerned
• b) authorised by a procedure compliant with a directly applicable EU
regulation
• Exceptions…
• Classification of human medicinal products for the purposes of dispensing and sale of
selected Pharmaceuticals
• RESEARCH, MANUFACTURE, DISTRIBUTION, PRESCRIBING, DISPENSING AND DISPOSAL OF
PHARMACEUTICALS
• Clinical trial
• Manufacture, preparation and distribution of pharmaceuticals
• Preparation of medicinal products
• Prescribing, dispensing of medicinal products and disposal of pharmaceuticals
• The implementing regulation
• Pharmacovigilance of medicinal products for human use
• Administrative delicts
• a fine may be imposed of up to:
• …… CZK, where an offence referred to in paragraph……
• Delegating provisions, Repealing provisions
• CHAPTER TWELVE
• EFFECT
Implementing regulations:
• Decree No 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended;
• Decree No 228/2008 Coll., on the marketing authorisation of medicinal products, as amended;
• Decree No 106/2008 Coll., on good practice of vendors of selected pharmaceuticals and a
professional training for vendors of selected pharmaceuticals
• Decree No 54/2008 Coll., on the method of prescribing medicinal products, particulars to
appear on medical prescriptions, and rules governing the use of medical prescriptions, as
amended;
• Decree No 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling
pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying
medicinal products, as amended;
• Decree No 85/2008 Coll., which lays down a list of active substances and excipients which may be
used in the preparation of medicinal products, as amended;
• Decree No 415/2017 Coll., on the implementation of certain provisions of the Pharmaceutical Act
on electronic prescriptions
• Decree No 226/2008 Coll., on good clinical practice and detailed
conditions of clinical trials on medicinal products, as amended;
• Decree No 86/2008 Coll., on the principles of good laboratory
practice in the area of pharmaceuticals, as amended;
• Decree No 143/ 2008 Coll., on defining detailed conditions to assure
the quality and safety of human blood and its components (Decree on
Human Blood), as amended;