European_Union.ppt.Nikhil[1].pptx

1
Prepared by : Nikhil Dilip Borade
Roll No. : 03
Branch : Regulatory Affairs
European Union Regulations

Content :
• Introduction
• Organization Chart
• History
• Active Substance Master File
• Approval Process Of IMPD
• EudraLex Directives
• Regulatory Consideration for Packing and Labeling of
Pharmaceuticals in EU.
• Certification of Suitability
• Marketing Authorization (MA) Transfer
• Legislation and Regulations of Cosmetics
2

INTRODUCTION
INTRODUCTION :
The European Medicines Agency (EMA) is the regulatory
agency of European Union.
The agency is in charge of scientific evaluation, supervision,
and reporting.
Pharmaceutical companies drugs are monitored for safety,
businesses for use in the European Union.
The European Medicines Agency (EMA) ensures that all
medicines accessible on the EU market are safe, effective,
and of high quality in 27 EU member states and the European
economic area.
EMA services a market of more than 500 million people
throughout the European Union.
3

HISTORY
HISTORY:
In 1995, a European medical agency was established, has
strived to preserve public and animal health in the EU and
around the world by subjecting medicines to rigorous
scientific scrutiny and giving stakeholders with impartial
science-based information on medications.
EMA has a 20-year track record of assuring efficacy and
safety of human and veterinary medicines in Europe as well
as encouraging research and innovation in medication
development.
6

EMA AND EDQM
EMA AND EDQM :
The EDQM ( European Directorate For Quality Medicines )
is an organization that protects public health by enabling the
development, supporting, implementation & monitoring
application of quality standards for medicines & their safe
use.
The European Medicines Agency (EMA) works with the
European Directorate for the quality of medicines &
healthcare.
7

Active Substance Master File
Introduction (Background) –
• ASMF procedure formerly known as the European Drug
Master File (EDMF). Procedure, is to allow valuable
confidential Intellectual property, while at same time
allowing the applicant or marketing Authorization holder to
take full Responsibility for the medicinal product & quality
Control of active Substance.
 Legal basis:
• Annex-1 to Directive 2001/83/EC as amended part 1,3.2
basic principles & requirements of Active Substance Masters
file (for human medicinal products) and Annex I to Directive
2001/82/EC as amended, part 2, C.1 general requirements
(for veterinary medicinal products).
8

Content of the Active Sub.
master file
Content of the Active Sub. Master File : -
• The overall content of the ASMF should contain detailed
scientific information as indicated under the various headings
of the relevant notice for marketing authorizations for
medicinal products in the member state of the European
Union.
• ASMF linked to human medicinal product should be
presented in the format of Common Technical Document
(CTD) see Annex-1, table-1.
• ASMF linked to veterinary medicinal products should
normally be presented in accordance with the format given in
Annex-1, Table-2.
15

Content of the Active Sub.
master file
• All parts of such ASMF (Applicant’s Part (AP) & Restricted
Part (RP) & their summaries) presented in the CTD format.
• The scientific information in the ASMF should be physically
divided into two parts
1) Applicant's part:
• AP contains the information that the ASMF holder regards
as non-confidential to applicant or market authorization
holder.
2) Restricted part :
• RP may contain the confidential information such as detailed
inf. on individual steps of the mfg. methods (reaction
Conditions, temp., validation and evaluation data of critical
steps.
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ACTIVE SUBSTANCE MASTER
FILE
• In addition to the AP & RP, the ASMF should contain a table
of contents, and separate summaries for both the AP & RP.
• In cases where the ASMF is provided in the CTD format,
both summaries should be presented as a Quality Overall
Summary (QOS).
• Each version of the AP and RP should have unique and
independent version control numbers.
oUse of the Active Substance Master File.
• ASMF Can only be submitted in support of an Marketing
Authorization Application (MAA) & Marketing
Authorization Variation (MAV).
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• The relationship between the quality of the active substance
and its use in the medicinal product needs to be justified in
this MAA or MAV.
• ASMF procedure can be used for the following active
substances
1. New Active sub.
2. Existing Active sub.
3. Pharmacopeias Active Sub.
The ASMF procedure can not be used for the Biological
Active Substance
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FILE
The ASMF holder may have an ASMF as well "Certificate of
suitability (CEP)" issued by European Directive Quality
Management for a single active substance.
The ASMF holder Should Submit to the Applicant /Market
Authorization Holder
1. A copy of Latest Version of Applicant part (AP).
2. A copy of the Quality Overall Summary (QOS).
3. A copy of Letter of Access (LOA).
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FILE
Changes and Updates to the ASMF :
• ASMF holder should keep the content of their ASMF's
updated with respect to the actual mfg. Process.
• ASMF holders shall not modify the contents of their ASMF
(e.g. Mfg. process or Specification) without informing each
Applicant / MA holder & each National Competent Authority
/ EMA.
• Any change to the ASMF should be reported by every MA
holder to the EMA- by means of an appropriate variation
procedure. A submission letter should be provided (Appex-
3).
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CONTENT AND APPROVAL
PROCESS OF IMPD
Introduction :
 The Investigational Medicinal Product Dossier ( IMPD) is
the documents containing information about an
Investigational Medicinal Product (IMP) related data required
whenever the performance of a clinical trial is intended in
one or more EU member states.
Content of IMPD :
The IMPD includes summaries of information related to the
quality, manufacturing & control of any investigational
medicinal product including (reference product & placebo) &
data from non-clinical & clinical studies.
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• Requirements of IMPD:
1. Although the IMPD is composed of a compilation of all the
data and the documents provided to each member state (MS)
which is required to obtain permission to start clinical trials,
there are also requirements of other supporting documents that
need to support the IMPD before the grant of approval by the
component authorities of each MS, as they may vary from
country to country.
2. Much of the information in the IMPD is contained in the IB
( Investigator Brochure) which is a very elaborative document.
3. In this case, applicant can either provide an independent
IMPD or cross-refer to the IB for the details required for
preclinical and clinical parts of the IMPD as the Investigators
Brochure (IB) which has adequate data, information to allow
assessors to finalize a decision about the clinical trial, the
possible toxicity of the IMP and safety or efficacy of its use in
the proposed trial.
22

CONTENT AND APPROVAL
PROCESS OF IMPD
The following is a listing of the data should be included in
the IMPD
oQuality Data :
 Quality data including summaries of chemical,
pharmaceutical & biological data on the IMP.
 Data should be based on the IMP's to be used for a clinical
trial whose manufacture Complies with principle of GMP
Applicant should also supply the following –
 A copy of manufacturing authorization Stating the scope of
the authorization if the IMP is manufactured in the Europe &
does not have marketing authorization in the EU.
 Certification of the GMP status of any active biological
substance.
 Copy of importer authorization.
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IMPD
oNon-clinical pharmacology :
 Non clinical pharmacology & toxicology data including
summaries of non clinical pharmacology & toxicology data for
any IMP to be use in the clinical trial.
oPrevious clinical Data :
 Previous clinical trials & human experience data section
providing summaries of all available data from previous clinical
trial & human experience with the proposed IMP.
o Overall Risk & Assessment :
 Overall risk & benefits assessment section should provide a
brief integrated summary that critically analyses the nonclinical
& clinical data in relation to the potential risk and benefits of
the proposed trial.
24

MARKETING AUTHORIZATION
PROCEDURE
o Marketing Authorization procedure in EU :
There are two regulatory steps to go through before a drug is
approved to be marketed in the European Union.
1. In clinical trial application.
2. Marketing Authorization Application.
There are four marketing authorization procedures:
1. Centralized procedure
2. Decentralized procedure
3. Mutual Recognition Procedure
4. National procedure
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Marketing Authorization Procedure
27
Centralized
Procedure
Large molecule – protein based
drug
Small molecule synthetic drug
Mutual
Recognition
Procedure
National
Authorization
Procedure
Abridge National
Authorization
Procedure
Generics

MUTUAL RECOGNITION
PROCEDURE
Mutual Recognition Procedure :
The mutual recognition procedures stated in council directive
93/39/EEC.
In essence, once a drug is approved for marketing
authorization by one member state , it is eligible to apply for
marketing authorization in other member stated through the
mutual recognition procedure.
 Identical application are submitted to those member states
where marketing authorization are sought.
The first member state that reviews the application is called
the ‘Reference Member State’, it notifies other states called
‘concerned member states’.
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NATIONAL PROCEDURE
National Procedure :
This procedure is used whenever a company wants to
commercialize product in only one EU member state.
The national procedure is specific to each country, that is
each country within the EU has its own procedure for
authorizing a marketing application for a new drug.
Sponsors can find information regarding to requirements &
procedures of each country on the website of regulatory
agencies.
To obtaining marketing authorization in a country, the
application must be submitted to the competent authority of
that member state in its own language.
31

EUDRALEX DIRECTIVES
• EUDRALEX stands for European Union drug Legislation
Medicinal Products for Human Use.
• EUDRALEX is the collection of rules and regulations
governing medicinal products in the European Union.
EUDRALEX consists of 10 volumes:
Concerning Medicinal Products for Human use:
1. Volume 1 ( Directive 2001/83/EC) – Pharmaceutical
Legislation.
“The rules governing medicinal product in the European
Union” complies the body of European Union legislation in the
pharmaceutical sector for medicinal product for human use.
32

EUDRALEX DIRECTIVES
2. Volume 2- Notice to Applicants and regulatory
guidelines medicinal product for human use.
a) Volume 2A deals with procedures for marketing
authorization.
b) Volume 2B deals with the presentation and content of the
application dossier.
c) Volume 2C deals with Guidelines
3. Volume 3- Guidelines for medicinal product –EMA
scientific guidelines
"The rules governing medicinal products in the European
Union" contains scientific guidelines prepared by the
Committee for Medicinal Products for Human Use (CHMP) in
consultation with the competent authorities of the EU Member
States, to help applicants prepare marketing-authorization
applications for medicinal products for human use.
33

EUDRALEX DIRECTIVES
• Guidelines are intended to provide a basis for practical
harmonization of the manner in which the EU Member States
and the EMA interpret and apply the detailed requirements
for the demonstration of quality, safety and efficacy
contained in the Community Directives.
Concerning Medicinal Products for human use in clinical
trials (investigational medicinal products).
4. Volume 4- Good Manufacturing Practices ( Directives
91/356/EEC as amended by Directive 2003/ 94/EC, and
91/412/EEC)
Part-1 : Basic Requirements for Medicinal Product.
Which contains 10 chapters ( e.g. personnel, premises and
equipment, production, quality control etc.)
34

EUDRALEX DIRECTIVES
• Part- 2 : Basic Requirements for Active Substance used as
starting materials
• Part- 3 : GMP related documents (e.g. site master file)
5. Volume 9- Pharmacovigilance ( Directives 2001/82/EC):
Volume 9A- Pharmacovigilance for medicinal product for
human use
Volume 9B- Pharmacovigilance for medicinal product for
veterinary use
35

EUDRALEX DIRECTIVES
Concerning Veterinary Medicinal Products:
6. Volume 5 - Pharmaceutical Legislation.
“The rules governing medicinal product in the European
Union” complies the body of European Union legislation in the
pharmaceutical sector for medicinal product for Veterinary use.
7. Volume 6 - Notice to Applicants.
The rules governing medicinal products in the European
Union" contains a list of regulatory guidelines related to
procedural and regulatory requirements such as renewal
procedures, dossier requirements for Type IA/IB variation
notifications, summary of product characteristics (SPC),
package information and classification for the supply,
readability of the label and package leaflet requirements.
36

EUDRALEX DIRECTIVES
Volume 6A - Procedure for marketing authorization
Volume 6B - Presentation and content of the dossier
Volume 6C – Regulatory guidelines on summary of product
characteristics
8. Volume 7 – Guidelines
The rules governing medicinal products in the European
Union" contains scientific guidelines prepared by the
Committee for Medicinal Products for Veterinary use (CVMP)
in consultation with the competent authorities of the EU
Member States, to help applicants prepare marketing-
authorization applications for medicinal products for human
use.
37

9. Volume 8 - Maximum residue limits.
“The rules governing medicinal products in the European
Union” contains guidance on the application of Council
Regulation (EEC) No 2377/90, as amended, which provides
the legal framework for the establishment of maximum residue
limits (MRLs) for medicinal products for veterinary use.
Concerning Medicinal Products for human use in clinical
trials (investigational medicinal products)
10. volume 10- Clinical trials
The “Rules governing medicinal product in the European
Union” contains the guidance documents applying to clinical
trials.
38

• Set of documents applicable to clinical trials authorized
under regulation EU No 536/2014
• Chapter - 1 : Applicant and Application documents
• Chapter - 2 : Safety reporting
• Chapter - 3 : Quality
• Chapter - 4 : Inspections
• Chapter - 5 : Additional documents
• Chapter - 6 : Legislation
39

Regulatory consideration for
manufacturing of pharmaceuticals in EU
Manufacturing of pharmaceuticals in EU.
• EU regulations require all pharmaceutical manufacturers to
comply with EU Good Manufacturing Practices (GMPs) if
they want to supply products to the EU.
• Manufacturers and importers must be authorized and
registered by a competent authority from a member state.
• Manufacturers and importers are regularly inspected by an
EU competent authority or other approved authority to check
compliance with the EU GMPs.
40

Part I Basic Requirements for Medicinal Products
• Chapter 1 Pharmaceutical Quality System
• Chapter 2 Personnel
• Chapter 3 Premises and Equipment
• Chapter 4 Documentation
• Chapter 5 Production
• Chapter 6 Quality Control
• Chapter 7 Outsourced Activities
• Chapter 8 Complaints, Quality Defects and Product Recalls
• Chapter 9 Self Inspection
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Part II: Basic Requirements for Active Substance
oTable of content :
• Introduction
• Quality Management
• Personnel
• Building and Facilities
• Process Equipment's
• Documentation and Records
• Material Management
• Production and In Process Control
• Packaging and Identification Labelling of APIs and
Intermediates
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• Storage and Distribution
• Laboratory Controls
• Validation
• Change Control
• Rejection and Refuse of Materials
• Complaints and Recalls
• Contracts Manufactures ( Including Laboratories)
• Specific Guidance for APIs Manufactured by Cell Culture
• APIs use in Clinical Trials
• Glossary
43

Regulatory Consideration for labelling of
pharmaceuticals in EU
The text of labelling:
• The Union authorisation of a medicinal product includes the
labelling text which is the same throughout the Union. Article
9, paragraph 4 (d) of the Regulation provides that must be in
annex of the favourable CHMP opinion the draft text of the
labelling proposed by the applicant and presented in
accordance with title V of the Directive.
44

Languages:
• Article 63(1), 1st and 2nd sub-paragraph of the
Directive provides that "The particulars for labelling
listed in Articles 54, 59 and 62 shall appear in an official
language or official languages of the Member State
where the medicinal product is placed on the market, as
specified, for the purposes of this Directive, by that
Member State The first subparagraph shall not prevent
these particulars from being indicated in several
languages, provided that the same particulars appear in
all the languages used".
45

Additional labelling information required by some
Member States: Article 60 of the Directive provides that
Member States may not prohibit or impede the placing on the
market of a medicinal product which labelling and package
leaflet comply with requirements of Title V of the Directive.
However in accordance with article 57, Member States may
require the use of certain
• Forms of labelling in order to ascertain:
• The price of the medicinal product,
• The reimbursement conditions of social security
organizations,
• The legal status for supply to the patient, in accordance with
Title VI of the Directive,
• Authenticity and identification in accordance with Article
54a(5). 46

Legal status:
• In accordance with Article 9(4)(b) and 10(1) of the
Regulation, the CHMP scientific opinion and the
Commission decision on the marketing authorization must
respectively include "details of any conditions or restrictions
which should be imposed on the supply or use of the
medicinal product concerned, including the conditions under
which the medicinal product may be made available to
patients, in accordance with the criteria laid down in Title VI
of Directive 2001/83/EC".
Marketing authorization number
47

Optional information under Article 62 of the Directive:
• The labelling may include symbols or pictograms designed
to clarify certain information and other information
compatible with the summary of the product characteristics
which is useful to the patient, to the exclusion of any element
of a promotional nature.
Local representative:
• Article 1, point 18a of the Directive defines the representative
of the marketing authorisation holder as “the person,
commonly known as local representative, designated by the
marketing authorisation holder to represent him in the
Member State concerned”.
48

Changes to the labelling:
• Article 61(3) of the Directive provides that: "All proposed
changes to an aspect of the labelling or the package leaflet
covered by this Title and not connected with the summary of
product characteristics shall be submitted to the authorities
competent for authorizing marketing. If the competent
authorities have not opposed a proposed change within 90
days following the introduction of the request, the applicant
may put the change into effect".
49

Regulatory Consideration for packaging of
pharmaceuticals in EU
• The text of the package leaflet: Article 9, paragraph 4 (d) of
the Regulation provides that must be in annex of the
favorable CHMP opinion the draft text of the package leaflet
proposed by the applicant and presented in accordance with
Title V of the Directive.
• Language: The package leaflet must be clearly legible in an
official language or official languages of the Member State
where the medicinal product is placed on the market, as
specified, for the purposes of this Directive, by that Member
State . The first subparagraph shall not prevent the package
leaflet from being printed in several languages, provided that
the same information is given in all the languages used".
50

Optional information under Article 62 of the Directive:
• Package leaflet may include symbols or pictograms designed
to clarify certain information and other information
compatible with the summary of the product characteristics
which is useful to the patient, to the exclusion of any element
of a promotional nature. It is recommended that proposals for
such inclusion are discussed with the EMA.
• Local representative
• Changes to the package leaflet: Article 61 (3) of the
Directive provides that "All proposed changes to an aspect of
the package leaflet covered by this title and not connected
with the summary of product characteristics shall be
submitted to the authorities competent for authorizing
marketing. If the competent authorities have not opposed a
proposed change within 90 days following the introduction of
the request, the applicant may put the change into effect". 51

Certification of Suitability
• The Certification of Suitability (CEP) is a certificate that
certifies compliance of the active pharmaceutical ingredients
(API) or pharmaceutical ingredients with that of the rules laid
down in the monograph of the European Pharmacopoeia
(EP).
• CEP should consist of an explicit description of the chemical
composition of the substances.
• The manufacturer should provide an evidence that the quality
of the substance is controlled by the monographs of the EP
and is granted by Certification Secretariat of the European
Directorate for the Quality of Medicines (EDQM).
52

• The CEP also helps to bridge the gap between health
authorities and industries, providing an added advantage for
API manufacturers to enter the EU market.
• The CEP is necessary for all the manufacturers and suppliers
who are seeking market authorizations for: Checking the use
of active substances to control the purity and quality of their
product.
53

Sister CEP submissions
• Any CEP holder who wishes to file for second CEP for the
same API can file a new application known as 'Sister CEP
submissions' or 'Sister File’.
• This application is valid for all the files except sterile, herbal
applications.
• This can be due to various reasons such as differences in API
specifications with an alternate process or to cover alternate
grade of material.
• A sister CEP is ideally, approved on a fast track basis
compared to the timelines of the original CEP applications.
• A set of pre-defined conditions are set by EDQM that must
be fulfilled in order to file a Sister CEP.
54

• Reaching out to an expert with information on sister CEP
will help in quick approvals of the application.
Requirements for Sister CEP submissions
• The manufacturer should be the same for both CEP and Sister
CEP application.
• The holder is same for both applications.
• The substance should be same as in the original document.
• The differences in the sister file and the original file should
be classified properly.
55

Marketing Authorization
Transfer
Marketing Authorization (MA) Transfer
• MAT is the procedure by which the MA is transferred from
the currently approved Marketing Authorization Holder
(MAH) to a new MAH which is a different person/legal
entity.
• Such a transfer may result from the MAH's commercial
decision to divest the MA or be needed in anticipation of the
MAH ceasing to exist as a legal entity and MA being taken
over by another legal entity.
• In case a MA Transfer is sought for several medicinal
products, an application must be submitted for each MA (i.e.
1 application per product).
56

 A Transfer of a MA can only be initiated once a MA has
been granted. In case there is a need to change the proposed
MAH during the initial Marketing Authorization Application
procedure, the applicant who initially applied for the MA is
advised to contact the Agency.
 The MAH of the MA to be transferred is termed the
Transferor.
 The person/legal entity to whom the Transfer is to be granted
is termed the Transferee.
57

The EU's role in cosmetics
Europe
The EU's role in cosmetics Europe
• EU is a world leader in the cosmetics industry and dominant
cosmetics exporter.
• The sector is highly innovative and provides significant
employment in Europe.
• The EU's involvement mainly concerns the regulatory
framework for market access, international trade relations,
and regulatory convergence.
• These all aim to ensure the highest level of consumer safety
while promoting the innovation and the competitiveness of
this sector.
• The European Commission is also in contact with cosmetics
stakeholders at EU and international level.
58

• Legislation Public consultation on the Cosmetic Products
Regulation
• On 4 October 2021, the Commission published an inception
impact assessment for the targeted revision of the Cosmetic
Products Regulation to meet the objectives of the EU
Chemicals Strategy for Sustainability. The deadline to
provide comments is 1 November 2021.
• Main legislation
• Regulation (EC) N° 1223/2009 on cosmetic products is the
main regulatory framework for finished cosmetic products
when placed on the EU market. It strengthens the safety of
cosmetic products and streamlines the framework for all
operators in the sector. The regulation simplifies procedures
to the extent that the internal market of cosmetic products is
now a reality. 59

• The regulation replaces Directive 76/768/EC which was
adopted in 1976 and had been substantially revised on
numerous occasions. It provides a robust, internationally
recognised regime, which reinforces product safety while
taking into consideration the latest technological
developments, including the possible use of nanomaterials.
The previous rules on the ban of animal testing were not
modified.
60

IMPORT OF COSMETICS IN EU
• Importing a foreign cosmetic brand into the European Union is
a complex process requiring compliance with strict regulations.
• Furthermore, the ability to sell under the label of organic'
requires surpassing even more regulatory standards.
• All regulations are designed and protect consumers and
cosmetic sellers must be in compliance with these standards in
order to sell their products within the EU.
• Although it is necessary for pharmaceutical products, marketing
authorization is not necessary for cosmetics in France and
Europe. The product, however, must be in compliance with
regulations that ensure they are in no way dangerous or
potentially harmful to the health of those who will use them.
61

• Marketing of your products requires:
• Informing the European Commission of your products. This
process is made possible by the New European Products
Notification Portal (CPNP).
• Availability of the Product Information File (PIF), whose
accessibility must be available at the products address (also
listed on the label).
• Consistent updates to the PIF as they become necessary.
• Compliance with all laws and regulations that control law.
62

Cosmetic Products Notification Portal (CPNP)
• The Cosmetic Products Notification Portal (CPNP) is a free
of charge online notification system created for the
implementation of Regulation (EC) No 1223/2009 on
cosmetic products.
• When a product has been notified in the CPNP, there is no
need for any further notification at national level within the
EU.
• Regulation (EC) No 1223/2009 (Article 13) requires that the
responsible persons and, under certain circumstances, the
distributors of cosmetic products submit some information
about the products they place or make available on the
European market through the CPNP.
63

The CPNP is making this information available
electronically to:
• Competent Authorities (for the purposes of market
surveillance, market analysis, evaluation and consumer
information)
• Poison Centre's or similar bodies established by EU
countries (for the purposes of medical treatment).
The CPNP is accessible to:
• Competent Authorities
• European Poison Centers
• Cosmetic products responsible persons
• Distributors of cosmetic products.
64

Products containing nanomaterials
• The CPNP also contains a separate module (Article 16) for
cosmetic products containing nanomaterials. This notification
has to be done in addition to the notification under Article 13.
If the European. Commission has concerns regarding the
safety of a nanomaterial, it may request the Scientific
Committee on Consumer Safety to perform a risk assessment.
INFORMATION REGARDING THE PIF
• The marketer is responsible for the maintenance of an up-to-
date Product Information File (PIF). This file must be readily
available for review at the address provided on the product
label.
65

• The PIF must include information relating to the components
of the product, its safety and its quality. So also, any potential
negative side effects must be explained and the expected
effect (purpose) of the product must be included. Products
manufactured within the European Union are under the
responsibility of the person or company selling the cosmetic
as their brand. Products that are imported from outside of the
EU are under the responsibility of the importer
The PIF must include : Explanation of the cosmetic.
oDetails pertaining to the product's safety. This includes:
• Product Make-up that identifies all ingredients and chemical
additions.
66

• Product characteristics o Information regarding the Challenge
Test o Source packaging materials .
• Any possible negative side effects that may occur from
product use.
• Details regarding the safety testing of the manufacturing
process and declaration of good manufacturing practice.
• Evidence of product claim veracity.
67

• The PIF must be available for verification at any moment.
Therefore it must be up to date and continually available for
review by authorities and regulators. Listed are three reliable
and well-known inspection organizations:
• 1.Inspectors of the ANSM (Agence Nationale de Sécurité du
Médicament)
• 2.Inspectors from the Ministry of Health
• 3.Inspectors of the Department of Direction of Protection of
the Populations.
68

• GMP FOR COSMETICS IN EUROPE
• ISO 22716 is an International Standard which gives
guidelines which are used as GMP guidelines in Europe for
the production, control, storage and shipment of cosmetic
products.
• These guidelines cover the quality aspects of the product, but
as a whole do not cover safety aspects for the personnel
engaged in the plant, nor do they cover aspects of protection
of the environment.
• Safety and environmental aspects are inherent
responsibilities of the company and could be governed by
local legislation and regulation.
• These guidelines are not applicable to research and
development activities and distribution of finished products.
69

EU GMP Guidelines For:
• Personnel Hygiene and Health
• Premises
• Equipment
• Raw material and Packaging material
• Production
• Finished Product
• Quality Control Laboratory
• Waste
• Internal Audit
• Documentation
70

References :
1. https://www.ema.Europe.eu/en
2. https://www.cosmeticseurope.eu/files/6214/7643/4067/ke
y_features_of_the_CPR.pdf
3. https://ec.Europe.eu/health/medicinal-
products/eudralex/_en
4. https://ec.Europe.eu/health/default/files/eudralex/vol-
2/2018_packaging_guidelines_en.pdf
5. https://ec.Europe.eu/growth/sectors/cosmetics_en
71

European_Union.ppt.Nikhil[1].pptx

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