Dr P V Appaji MPharm PhD Director General PHARMACEUTICALS EXPORT PROMOTION COUNCIL OF INDIA Hyderabad Email dgpharmexcilcom Presentation by CONTENTS Which are EU Countries ID: 539982
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Slide1
EU Directive 2001/83/EC
Dr. P. V. Appaji, M.Pharm, Ph.DDirector General,PHARMACEUTICALS EXPORT PROMOTION COUNCIL OF INDIAHyderabadEmail: dg@pharmexcil.com
Presentation bySlide2
CONTENTS
Which are EU Countries?Objectives of EU Directive 2001/83/ECDefinition of Falsified Medicinal ProductPotential targets of EU Directive 2001/83/ECCurrent Indian Pharmaceutical Industry StatusAdvantages with EU Directive to IndiaDisadvantages with EU Directive to IndiaPossible NegotiationsSlide3
Which Are
EU Countries?Slide4
Objectives Of EU Directive 2001/83/EC
Introduction of a New Term Falsified Medicinal ProductAims to prevent suspected medicines reaching patientsSafety features to be harmonised within the UnionAims safety measures All through the supply chain (manufacturer to end user)
Contd
…Slide5
Prevent distortions in the internal market
Prevent falsified medicinal products entering the legal supply chainAims at Ensuring Good Manufacturing Process of EU/EU Pharmacopoeia standardsAims at Pharmaceutical product quality for APIs, Generics formulations, Excipients at the manufacturing level
Objectives Of EU Directive 2001/83/ECSlide6
EU Defines Falsified Medicine As
Any medicinal product with a false representation of:Its identity, inclusive of package and labeling, its name or its composition as regards to any of the ingredients inclusive of excipients and the strength of those ingredients;
Its source
, its manufacture, its country of manufacturing, its country of origin or its marketing authorisation holder;
Its
history
:
The records and documents relating to the distribution channels used
The definition Excludes unintentional quality defects and is without prejudice to infringements of intellectual property rightsSlide7
Potential Targets Of EU Directive 2001/83/EC
Confirming GMP with audits (for APIs, formulations, Excipients)Confirming distribution with auditsConfirming GMP practices at least
equivalent to those laid down by the UnionNotification to the authority for any changes that may impact on the quality or safety of the active substances that are manufactured, imported or distributed
Contd
…Slide8
Implementation of anti-tampering devices
Maintaining records in the form of purchase/sales at various levels of supply chainPersons brokering medicinal products are also subject to inspection by competent authoritiesPersons brokering must have permanent address, contact details in the Union
Potential Targets Of EU Directive 2001/83/EC
Contd
…Slide9
Repeated inspections of Manufacturers (located in the Union or in third countries) and wholesale distributors of medicinal products
Inspections of the premises of marketing authorisation holders and of brokers of medicinal products are possibleData submitted to comply with monographs of European PharmacopoeiaPotential Targets Of EU Directive 2001/83/ECSlide10
Current Indian Pharmaceutical Industry Status
India is a leading exporter of quality pharmaceutical products globallyIndian exporters comply with ISO, GMP/WHO GMP, ICH guidelines etc.,Indian Drugs & Cosmetic Act terminology - Spurious drugs
- Not of standard quality or substandard drugs - Adulterated drugs - Misbranded drugs
may fall under the purview with international actsSlide11
EU
rules for import of API’s. According to Articles 46b 2(b) i, ii & iiiWritten confirmation from the competent authority of the exporting third country of the following:
The standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the
Union.The manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union
;
In
the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without any delay.
Directive 2001/83/EC
as amended by
Directive 2011/62/EUSlide12
Implementation Of The New Directive
Concept paper submitted for public consultation.
“Implementing act on the requirements for the assessment of the regulatory framework applicable to the manufacturing of Active Substances of Medicinal products for Human Use”.
Consultation closed on March 23 , 2012.
Implementation date : July 2013Slide13
Written
confirmation waived for countries to be listed as per Article 111b.Third country to request for “Equivalence assessment” Assessment to be done by the commissionIf assessment confirms equivalence , third country will be included in the list.Regular verification thereafter.
Written Confirmation & Equivalence Assessment
(111b)Slide14
A review of relevant documentation
An on-site review of the third country's regulatory system, unless a mutual recognition agreement ('MRA') is in place that covers the manufacturing of active substances; andIf necessary, an observed inspection of one or more of the third country's manufacturing sites for active substances.
Equivalence Assessment Slide15
Third countries rules for
GMP implementationPending the adoption of a delegated act on the principles and guidelines of good manufacturing practice for Active SubstanceEU rules to be taken
into account are contained in Part II of the good manufacturing practice guideline of the EU (Eudralex Volume 4).
Country's Rules For GMP
(111b(1)(a))Slide16
Article 111b(3
)The Commission shall verify regularly whether the conditions of the GMP equivalence are fulfilledThe first verification shall take place no later than three years after the country has
been included in the list.
Regular VerificationSlide17
The manufacture of active substances should be subject to good manufacturing practice regardless of whether those active substances are manufactured in the Union or imported.
With regard to the manufacture of active substances in third countries, it should be ensured that the legislative provisions applicable to the manufacturing of active substances intended for export to the Union, as well as inspections of facilities and enforcement of the applicable provisions, provide for a level of protection of public health equivalent to that provided for by Union law.
Minimum Expectations Of New DirectiveSlide18
A
written confirmation that the manufacturer of the medicinal product has verified, compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits, in accordance with point (f) of Article 46. The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.
Responsibility of Formulators in the new directiveSlide19
Global Bulk Drugs Imports Region Wise
(Values In US$ Mn)
Sr.
no
Region
2008
2009
2010
YOY %
%share
1
EU
14794.04
15649.54
16673.38
6.54
50.58
2
North America
7379.52
4494.00
3866.23
-13.97
11.73
3
LAC
2180.33
3338.82
3611.87
8.18
10.96
4
Asia (Excluding Middle East)
2337.40
2445.33
2611.03
6.78
7.92
5
Other European Countries
1483.95
1045.19
1680.84
60.82
5.10
6
Asean
1211.84
1250.18
1255.68
0.44
3.81
7
South Asia
1069.94
1079.49
1082.13
0.24
3.28
8
Middle East 761.60599.14995.2366.113.029Africa 420.60423.74450.696.361.3710Oceania 392.32368.32378.672.811.1511CIS 261.88385.31355.17-7.821.0812Other America 4.375.436.1914.100.02 World 32297.7931084.4932967.116.06
Source : UN COMTRADESlide20
PIC/S
Pharmaceutical Inspection Convention (PIC)&Pharmaceutical Inspection Co-operation Scheme (PICS)Slide21
PICS Established in 1995.
Current members – 40 Participating Authorities Partners
a) EDQM European Directorate for Quality of Medicines and Health Care, France
b) EMA- European Medicines Agency
c) UNICEF
d) WHO
Requirements :
Law on medicinal products.
A GMP guide equivalent to PIC/S or EU GMP Guide.
A GMP inspectorate fulfils PIC/S quality system requirements.
Experienced GMP inspectors
Brief note on PIC/SSlide22
Objective of PIC/S
An active and constructive co-operation in the field of GMP.
To facilitate networking
between participating authorities and to increase mutual trust, to
exchange
information
and
experience,
in the field of GMP and related areas, and
mutual
training
of GMP inspectors.
Attain confidence of drug regulatory authority.
Avoid duplication
relating to
→
Inspections
→
Licensing
procedures
→
Expenditure
→
One
time
procedureSlide23
Mutual recognition of Inspections.
Harmonisation of GMP requirements. Uniform inspection systems.Training of inspectors.
Exchange of information.
Mutual confidence.
Goals of PIC/SSlide24
PIC/S Constituted fee 8,100 CHF
PIC/S Committee meetings – 2 per annumSeminars - 1 per year.Expert Circle meetings 3- per annum
Events duration are 1 to 3 days in other PIC/S countries.
Registration fee 8100 CHF & In assessment process, annual fee is 50% of Reg. fee f
or expert.
Financial CostsSlide25
PIC/S is not a trade agreement.
Membership in PIC/S may facilitate the export of pharmaceuticals.Non-PIC/S Countries (e.g. Colombia) may accept accreditation of PIC/S participating Authorities. Consequently, the Pharmaceutical industry located in these countries indirectly benefits PIC/S membership.
Benefits