BRAZIL, ASEAN, CIS, AND GCC COUNTRIES PPT/PDF

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BRAZIL, ASEAN, CIS, AND GCC COUNTRIES

1 ASIAN Countries
a. Introduction to ACTD
b. Regulatory Requirement for registration of drug and approval requirement in
chaina and south Korea & Association of Southeast Asia Nation Region
2. CIS
a. Regulatory prerequisites related to Marketing authorization requirement for
drug and post approval requirement for drug and post approval requirement in
CIS

3. GCC (Gulf Cooperation concil)

a. Regulatory pre-requisites related to marketing authorization requirement
for drugs and post approval requirement in saudi Arabic and UAE
4.Legislation and regulation for import,manufacture,distribution ,and sale of
cosmetics in cosmetics in brazil,asean,CIS and GCC countries

Introduction to ACTD

1. ASEAN Common Technical Dossier This ASEAN CommonTechnical Dossier (ACTD) is a
guideline of the agreed upon common format for the preparation of a well-structured
Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory
authorities for the registration of pharmaceuticals for human use. This guideline describes
a CTD format that will significantly reduce the time and resources needed to compile
applications for registration and in the future, will ease the preparation of electronic
documental submissions. Regulatory reviews and communication with the applicant will
be facilitated by a standard document of common elements.

2 Sections of ACTD

1. PART I: Table of contents, Administrative Data & Product Information(Applicable)
2. PART II: Quality Documents(Applicable)
3. PART III: Non Clinical Documents(Not Applicable for generic products)
4. PART IV: Clinical Documents(Not Applicable for generic products some exception

may apply)

3 ACTD Guideline

Part I :Table of ContentAdministrative Information and Prescribing Information

1. Section A: Introduction
2. Section B: OverallASEAN CommonTechnical DossierTable of Contents
3. Section C: Documents required for registration (for example, application forms,

labeling, Product Data Sheet, prescribing information)

Part II : Quality Document Section

1. A:Table of Contents Section

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2. B: QualityOverall Summary Section
3. C: Body of Data

4 ACTD Guideline Part III : Nonclinical Document Section

1. A:Table of Contents Section
2. B: Nonclinical Overview Section
3. C: Nonclinical Written andTabulated Summaries Table of Contents Pharmacology

Pharmacokinetics Toxicology Section
4. D: Nonclinical Study Reports Table of Contents Pharmacology Pharmacokinetics

Toxicology

5 ACTD Guideline

Part IV : Clinical Document

a. Section A: Table of Contents
b. Section B: Clinical Overview
c. Section C: Clinical Summary

• Summary of Biopharmaceutics and Associated Analytical Methods
• Summary of Clinical Pharmacology Studies
• Summary of Clinical Efficacy
• Summary of Clinical Safety
• Synopses of Individual Studies

d. Section D: Tabular Listing of All Clinical Studies

e. Section E: Clinical Study Reports

f. Section F: List of Key Literature References

Regulatory Authority for drug registration in China

The National Medical Products Administration (NMPA) is the main regulatory authority responsible
for drug registration management, formulating drug registration specifications, and organizing drug
registration review and approval.

NMPA’s Drug Evaluation Center (CDE) is responsible for the review of drug clinical trial applications,
drug marketing authorization applications, supplementary applications, and drug re-registration
applications for overseas manufactured drugs.

Who can apply for drug registration in China?

The Marketing Authorization Holder (MAH) can submit applications for drug clinical trials, drug
marketing authorization, re-registration, and supplementary applications. Along with these duties,
MAH can also handle various other duties.

Medicinal product registration categories in China

The requirements to develop and register a medicinal product in China depend on further
classification:

1. Chemical medicine

2. Biological products

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3. Traditional chinese medicine.

Each type is then classified into three registration categories, which determine the materials that the
applicant must provide as part of its registration application example clinical trial application,
marketing authorization application, etc.

For chemical medicines, registration categories are as follows

1. Innovative drugs

2. Improved new drugs

3. Generics

For biologics, registration categories are as follows

1. Innovative biological products

2. Improved new biological products

3. Marketed biological products (including biosimilars)

The corresponding application materials requirements are based on the product characteristics,
degree of innovation, and review management needs of the registered medicines.

The drug category in which an applicant chooses to register decides the clinical trial application
review and approval process. NMPA manages the clinical trial application.

The review process for drug marketing authorization

❖ After completing the pre-clinical studies and clinical studies supporting the drug registration, the
applicant should submit the drug marketing authorization application according to the
requirements.

❖ After the formal examination of the application materials, acceptance will be given if they meet
the requirements.

❖ The Drug Evaluation Center (CDE) organizes pharmacy, medical, and other technical personnel to
review the accepted drug marketing authorization applications.

❖ After the conclusion of the comprehensive review, issues a registration certificate for drugs. If
the conclusion of the comprehensive review is not passed, the application is disapproved.

 

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Process flow

Drug registration certificate validity and re-registration

The validity period of the drug registration certificate of drug Marketing Authorization Holder is five
years. During the validity period, the MAH must take responsibility of the safety, effectiveness and
quality controllability of the listed drugs and apply for drug re-registration six months prior the
expiration of the validity period.

Accelerated approvals for drugs registration

According to the regulation, NMPA initiated new drug review process and has divided the approval
process into the following four categories

❖ Breakthrough approval

❖ Priority review

❖ Conditional approval

❖ Special approval

The applicant needs to know for which category of drugs do these review processes apply at which
stage of drug development may apply.

Registration fees for review and approval

The applicant is required to pay a fee per applicable regulations. The National Medical Products
Administration (NMPA) charges the drug registration fees to review and approve clinical trials as a
part of the drug registration process. The fees are different categories of drugs as below.

❖ New drugs made in China

❖ New drugs made outside China

❖ Generic drugs made in China

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❖ Generic drugs made outside China

Post approval process of southkorea

To improve the safety management system of post-approval marketed drugs, the current Post-
Marketing Safety System based on the ‘Re-Examination System’ (every 4 – 6 years) will be changed
to the one based on the full product life-cycled Risk Management Plans (RMPs).

This change is for international harmonization of the safety management system after drug
marketing, strengthening of the analysis of collected safety information, enhancing the “drug
monitoring”and establishing a new data protection system.

The Post-Marketing Safety System change will be completed by the end of 2022 in a 3-step plan.

Step 1: (~2020): resolve the duplication of data due to the simultaneous implementation of the risk
management plan and re-examination. Improvements to post-marketing safety study regarding
number of subjects to be calculated and applied according to the prevalence rate, indications; etc.
that matches the characteristics of the drug.

Step 2: (~2021): Strengthening risk management plan efficiency by preparing the legal basis for
the’Risk Management Plan’ and clarifying implementation details such as Integration of targets for
re-examination and risk management plans, improved procedures/timelines for submitting risk
management plans, regular and up-to-date PSUR and more analysis of abnormal cases.

Step 3 (~2022): Achieve international harmonization of the post-marketing safety management
system of drugs by unifying the risk management plan for the re-examination system and
establishing a separate data protection system. Introduce intensive market monitoring to actively
collect drug use information for a certain period of time immediately after marketing for drugs with
limited safety information.

The Association of Southeast Asian Nations (ASEAN)

Overview

The Association of Southeast Asian Nations (ASEAN) is Southeast Asia’s primary multilateral
organization, a 10- member grouping of nations with a combined population of 660 million and a
combined annual gross domestic product (GDP) of around $3.1 trillion in 2021. Established in 1967,
it has grown into one of the world’s largest regional fora, representing a strategically important
region straddling some of the world’s busiest sea lanes, including the Straits of Malacca and the
South China Sea. Taken collectively, ASEAN would rank as the world’s fifth-largest economy and the
United States’ fourth-largest export market.

ASEAN’s members are Brunei, Burma (Myanmar), Cambodia, Indonesia, Laos, Malaysia, the
Philippines, Singapore, Thailand, and Vietnam. Members rotate as chair: Cambodia is ASEAN’s chair
for 2022 and Indonesia is to assume the chair in 2023. ASEAN engages in a wide range of diplomatic,
economic and security discussions through hundreds of annual meetings and through a secretariat
based in Jakarta, Indonesia. In 2008, the United States became the first non-ASEAN nation to
appoint a representative to ASEAN, and in 2011 it opened a U.S. mission to ASEAN in Jakarta with a
resident Ambassador. Several other nations have followed suit. President Biden plans a formal
meeting with ASEAN’s leaders March 28-29 in Washington, DC. ASEAN is a diverse and informal
organization. Two of its core operating principles are consensual decisionmaking and
noninterference in the internal affairs of its members. Some observers argue that this style

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constrains ASEAN from acting strongly and cohesively on important issues. Others argue that these
principles—dubbed the “ASEAN Way”—promote regional stability and ensure that the group’s
members continue to discuss issues where their interests sometimes diverge. The principle has been
tested as ASEAN seeks to address the crisis that has followed the Burmese military’s 2021 coup
d’etat.

ASEAN and Asian Regional Architecture Asia has no dominant EU-style multilateral body, and many
observers see the region’s economic and security institutions as underdeveloped. ASEAN convenes
and administratively supports a number of regional fora that include other governments (known as
“dialogue partners”), including the United States. ASEAN Member governments deeply value what
they call “ASEAN Centrality” in the evolving regional architecture. The ASEAN Regional Forum (ARF),
first convened in 1994 with 26 Asian and Pacific states plus the EU, was formed to facilitate dialogue
on political and security matters. The East Asia Summit (EAS), created in 2005, is an evolving leaders-
level forum with a varied agenda, in which the United States gained membership in 2010. The EAS
includes all 10 ASEAN members, plus Australia, China, India, Japan, New Zealand, Russia, South
Korea, and the United States. The ASEAN Defense Ministers Meeting-Plus (ADMM+), established in
2010, brings senior defense officials from EAS members together regularly and hosts multilateral
military exchanges. In recent years, as cooperation through non-ASEAN regional groupings such as
the Quadrilateral Security Dialogue and the Australia-U.K.-U.S. (AUKUS) security grouping has
deepened, some Southeast Asian observers have expressed concern about ASEAN’s place in U.S.
strategy. The Biden Administration casts its March 2022 summit with ASEAN leaders as a tangible
demonstration of U.S. commitment to the organization. Source: Graphic created by CRS. U.S.-ASEAN
Relations The United States has long had strong bilateral relations with individual Southeast Asian
nations, including treaty alliances with the Philippines and Thailand and a close security partnership
with Singapore. Many U.S. policymakers see engagement with ASEAN as complementing bilateral
relationships and strengthening the region’s collective diplomatic weight as other regional players
gain in economic and military power. The United States initially supported ASEAN as a means to
promote regional dialogue and as a bulwark against Communism, becoming an ASEAN Dialogue
Partner in 1977. In 2009, the United States acceded to the ASEAN Treaty of Amity and Cooperation
and committed to an annual U.S.-ASEAN Meeting. In 2012, the United States and ASEAN agreed to
raise the level of the U.S.-ASEAN meeting to a Leaders Meeting, and in November 2015 announced a
U.S.-ASEAN Strategic Partnership.

 

CIS COUNTRIES The Commonwealth of Independent States (CIS) was established (December
1991):

when the implementation was officially confirmed, the members of the Union declared their
participation (equality of sovereignty). Currently, the CIS countries consist of 13 members, the list of
which is given in Table 1. The Single Economic Space was established based on the open movement
of goods, employment, services, and capital by the heads of the CIS countries (1993). An agreement
was approved for the corporation to merge the conduct of the regulation of economic movements
into a business agreement. The agreement also provides constructive necessities for the growth of
direct production links. The agreement was signed in four countries (Russia, Kyrgyzstan, Kazakhstan,
and Belarus), and the Union of the Sovereign Republic was established in 1995 to set up relevant
coordinating bodies (Belarus and Russia)

 

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Medical Devices in GCC Countries

3.1.1 Kingdom of Saudi Arabia (KSA)

Medical Devices Definition

The Medical Devices and In Vitro Diagnostic (IVD) definitions in Saudi Arabia are based on the IMDRF
definition [49] (see section 2).

a. Medical Devices Regulation

As KSA is an active member of AHWP, the most Medical Devices regulations are based on IMDRF and
consequently GHTF requirements. These regulations ensure that only Medical Devices that have
been authorized by one of the founding IMDRF members have access to the Saudi Arabian market.
The Saudi Arabian Food and Drug authority (SFDA) was established in 2003 and is still constructing
the regulatory infrastructure for Medical Devices registration. The SFDA is operating through a
Medical Devices Interim Regulations (MDIR) system. The SFDA is an independent authority that
reports to the council of ministers and is responsible for the regulation of Medical Devices in Saudi
Arabia [50].

The MDIR is facilitated through a set of Electronic systems51 [Country Questionnaire, 2014] and
solutions to enable manufacturers, Authorized Representatives, Importers, Distributors, and other
parties to communicate efficiently with the SFDA. The electronic application forms (Annex V) are
found on the Medical Devices Marketing Authorization (MDMA) portion of the SFDA’s website [52]
[Country Questionnaire, 2014].

The Medical Devices interim regulation applies to the following parties and products49:

• Manufacturers, authorized representatives, importers and distributors.

• All Medical Devices and their accessories that will be supplied to the KSA market.

• Contact lenses and laser surgical equipment for cosmetic rather than medical purposes, and their
accessories.

Medical Devices may be placed on the market only if they comply with the applicable provisions of
this MDIR [51, 53 54].

A local representative is required to handle the registration application on behalf of the foreign
manufacturer.

b. required documentation

According to article 18 of MDIR, in order to register a Medical Devices, the applicant is asked to
submit the following documentation to SFDA [52, 55-59].

• Application form (Annex V);

• Letter of Authorization (LOA);

• Manufacturer and Saudi Authorization representative details;

• GMP certificate or QM- system certificate (ISO 13485, ISO 9001);

• Recent Audit Report;

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• Other Certificates as required by the Devices class;

• Documents supporting the market authorization in reference IMDRF market;

• Declaration of Conformity, written in English; The declaration of conformity clearly identifies to
which Medical Devices it applies and attests that the Medical Devices complies with the regulatory
requirements of the relevant IMDRF Founding Member and also complies with the national
provisions of MDIR.

• Environmental statements : Statement attesting that the Medical Devices complies with the
regulatory requirements of the relevant IMDRF Founding Member jurisdiction and also complies
with the national provisions of this Interim Regulation (Annex VI);

• The applicant shall indicate, which of the GHTF Founding Member(s) allows the Medical Devices
that is the subject of the MDMA application, onto its market; and

• Regulatory Compliance Attestation:

Statement confirming that the applicant will comply with the KSA’s National Centre for Medical
Devices Reporting (NCMDR) requirement and any Filed Safety Corrective Action affecting the
Medical Devices be reported to KSA authorities (Annex VII).

Moreover, the following Technical documents are requested for submission:

• A copy of the Medical Devices information including labelling, Intended use, instruction for use
(IFU) and marketing materials, in English and/ or Arabic language;

• Specifications or similar documents that ensure, that the Medical Devices are correctly stored,
transported, installed and maintained in the KSA, and users can be trained in their proper use

; • A report of any relevant adverse event, that involves the Medical Devices, be submitted to SFDA’s
National Centre for Medical Devices Reporting (NCMDR) [60].

c. Pre-Owned Medical Devices Used or refurbished medical equipment is allowed entry into Saudi
Arabia. However, the Ministry of Health and other Saudi government hospitals keep away from
purchasing such equipment [49, 60].

d. Post marketing surveillance The NCMDR receives reports of suspected Medical Devices adverse
events and confirmed product recalls from healthcare practitioners and Devices suppliers within the
Kingdom of Saudi Arabia [62].

e. Country Specifics

. Enforcement of Medical Devices Marketing Authorizations .

All Medical Devices & IVDs intended to be marketed in Saudi Arabia should have a valid Medical
Devices Marketing Authorization (MDMA) as per the following enforcement dates [63].

 

Class Types Enforcement Date

Hight In Vitro Diagnostics 1 th October 2012

Medical Devices 1 th December 2012

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Medium In Vitro Diagnostic 1 th December 2012

Medical Devices 31th December 2014

Low Risk In Vitro Diagnostics 30th June 2015

Medical Devices 31th December 2015

 

 

United Arab Emirates (UAE)

Medical Devices Definition

The Medical Devices and In Vitro Diagnostic (IVD) definition in the UAE are the same as in the KSA
based on the GHTF definition [64] (see section 2.2.3).

a. Medical Devices Regulation The UAE are like the KSA a member of the AHWP and the Medical
Devices are regulated by the Ministry of Health (MOH) in the United Arab Emirates [65].

UAE Medical Devices regulations are substantially orientated towards GHTF guidelines as well as
towards EU requirements. Classification requirements and the evaluation of Devices follow
international regulations and guidelines, mainly those of:

• the IMDRF for Medical Devices,

• the US Food and Drug Administration’s Devices Regulation,

• the EU Medical Devices Directive 93/42/EEC,

• the EU in Vitro Diagnostic Devices Directive (IVDD) 98/79/EC and

• the EU Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.

The similarity between the classification of medical Devices and the registration Guideline of the
MOH is shown by the fact that certain definitions are very close to those provided by the EU Medical
Devices Directive [66].

The guidelines provide for a simplified registration process for Devices that have received approval
from recognized regulatory agencies, such as those in Europe, the US, Australia, Canada or Japan.

The Medical Devices manufacturers must be registered with the Ministry before they can market
their products in the UAE. Companies who wish to export their products into the UAE must engage a
local representative or distributor with a licensed medical store for registration of their products
with the MOH.

In order to register a Medical Devices in the UAE, the product as well as the company must be
registered there. The appointed local representative or distributor must submit a Medical Devices as
well as a manufacturer’s company registration application form (Annex IIX) to the Ministry’s Drug
Control Department.

b. Required documentation

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1. Product registration In order to register a Medical Devices, the applicant is asked to submit the
following documentation in Arabic or English language to the MOH. The documentation varies
depending on the Devices classification [64].

Table 9: UAE Medical Devices regulation: the required attachments per Devices Class [64]
Documentation Class I/ General IVD A Class II/ Class B IVD Class III/ Class C IVD Class

Documentation Class I/ General Class II/ Class Class
IVD A Class B III/

IV/
IVD Class C

IVD Class D

IVD

Application Form (Annex IIX for the company ✓ ✓ ✓ ✓
and Annex IX for the product

CE certificate and FSC(both legalized by the ✓ ✓ ✓ ✓
chamber of commerce and the UAE embassy

Declaration of Conformity / Evidence of ✓ ✓ ✓ ✓
Conformity to the essential principles

Company registration certificate legalized by ✓ Self ✓ ✓ ✓
the chamber of commerce and the UAE declara
embassy in country of origin tion

Status of devices distribution ✓ ✓ ✓ ✓

Declaration of prices NA ✓ ✓ ✓

Essential principle checklist ✓ ✓ ✓ ✓

Post-market requirements/ vigilance system ✓ NA ✓ ✓
and risk assessment

Manufacturing process: 1. Process Validation NA NA ✓ ✓
Studies 2. Software validation studies (if
applicable)

Safety and effectiveness data, risk assessment, NA NA ✓ ✓
pre-clinical and clinical studies

Labeling & samples • Three copies (artwork) of ✓ ✓ ✓ ✓
each product packaging, labeling and
promotional material • Sample (if applicable).
• Labeling and packaging must have: the
product name, name and address of the
company printed in English and/or Arabic,
manufacturing date and/or expiration date,
Medical Devices for single use must be labeled
accordingly on the outer pack

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Shelf life study ✓ ✓ ✓ ✓

 

 

2. Company registration In the UAE

the company registration file should be submitted at the same time as the registration files of its
product/s [64]

Companies’ registration requirements

• Application for the medical Devices company (Annex IIX),

• company business license,

• LoA,

• organization of the quality assurance system (flow chart),

• notarized copies of relevant certificates for Quality Accreditations from recognized notified bodies
for each manufacturing facility involved in the manufacturing of the medical Devices intended for
registration in the UAE,

• for classes III & IV / IVD C & D manufacturer: copies of the Design Examination, Type Examination
certificates or equivalent health authority approvals issued for these Devices should be provided as a
proof of compliance of the company with best practices,

• a recent audit report.

• The general profile has to include the following Information:

a. Company name, address, including the corporate structure as well as all company names of the
company and its manufacturing sites used,

b. contact name, telephone, fax numbers and e-mail addresses,

c. total number of employees (all shifts) covered by the scope of the audit,

d. product range and class of Medical Devices being manufactured (the class of a medical Devices
may differ from one the regulatory authority of one UAE country to another),

e. types of Medical Devices sold and/or planned to be sold in the UAE and/or GCC regions for which
the regulatory requirements will be assessed, including a complete list of authorizations (e.g.
licenses) issued for those Medical Devices (where applicable),

f. location and function of each site,

g. a list of activities performed at each site,

h. special manufacturing processes, e.g., software, sterilization, etc.

Furthermore, the technical documentation is required for submission, e.g. the following documents:

• Site Master File for each manufacturing site (if applicable),

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• Warehousing information and general dispatch information as well as the implemented quality
management system,

• validation and verification processes for sterilized products and

• the general post marketing surveillance plan.

If the company has multiple manufacturing sites, each manufacturing location should be identified
as follows indicating the manufacturing step carried out there (see application for company
registration).: design, production, sterilization, packaging, labeling and final release

c. Country Specifics

After approval of the application, a registration number is given, which is valid for five years

. A registration number can be revoked [65, 67], if

• the applicant requests for it or

• upon failure to meet the standards based on assessment or monitoring proving that –

the Devices are unsafe and/or harmful,

– the quality of the Devices is substandard,

– the Devices differ from the approved label.

Importation Rules A

pre-approval for importation of the consignment is issued by Drug Registration and Control
Department for importation of Medical Devices. This will be only allowed for importers with a MOH
medical store license. Documents to be attached to the consignment pre-import approval
application form are:

1. the legalized ISO 13485 by the UAE Embassy;

2. FSC / documentation or letters of regulatory approval / relevant CE certification/ clearance to
manufacture, sale, import and export of the Medical Devices from the competent authority in the
exporting country and the

3. declaration of conformity. The control of Medical Devices will be based on an implemented risk
assessment and risk management.

d. Pre-Owned Medical Devices

Used Medical Devices are not allowed for importation into and marketing in the UAE. REFERRANCE:
https://www.dgra.de/media/pdf/studium/master MAJOR COSMETIC LEGISLATION IN BRAZIL:

TOPIC Brazil REGULATIONS
TOPIC REGULATIONS
Registration ➢ RDC 07/2015: Technical requirements for the regularization

of personal care products, cosmetics and perfumes.
➢ RDC 15/2015: Technical requirements for the regularization

of children’s personal care products, cosmetics and
perfumes.

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➢ RDC 19/2013: Technical requirements for granting
registration of insect repellent cosmetic products.

➢ RDC 237/2018: Changes some topics of the RDC 07/2015 and
➢ RDC 15/2015.

Labeling ➢ RDC 07/2015: Chapter II / Annex V / Annex VI.
➢ RDC 250/2018: Requirements for the presentation of the Art

of Labelling Project in the process of regularization of
personal care products, cosmetics and perfumes, and for the
coexistence of more than one art of labeling or labeling for
the same product.

Ingredients ➢ Updated F List of PRT 344/1998 : substances outlawed in
Brazil ¾ RDC 83/2016 : List of substances that cannot be used
in toiletries, cosmetics and perfumes

➢ RDC 3/2012 : List of substances that toiletries, cosmetics and
perfumes should not contain Except under the conditions
and restrictions laid down

➢ RDC 29/2012: List of permitted preservative-acting
substances for toiletries, cosmetics and perfumes

➢ RDC 44/2012: List of permitted coloring substances for
toiletries, cosmetics and perfumes

➢ RDC 69/2016: List of allowed ultraviolet filters for toiletries,
cosmetics and perfumes

 

 

COMPANY OPERATING AUTHORIZATION (AFE)

In order to manufacture or import Class II Cosmetics in Brazil, local companies must have a
Company Operating Authorization (AFE) for such products and a License from Anvisa. The Certificate
of Authorization of Operation (Certificate of AFE) is a document issued by Anvisa proving that the
company is authorized to perform the activities described in the certificate. It contains data such as
the company’s authorization number and address. Without having the Company Operating
Authorization at ANVISA, the company cannot obtain the next approval, which is the Regulation of
national and imported products.

AFE is required from companies that perform activities of:

• Production / Manufacturing

• Distribution

• Storage

• Export

• Import

ASEAN

 

APPLICABLE LEGISLATION

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The Association of Southeast Asian Nations (ASEAN) consists of 10 countries: Brunei, Cambodia,
Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. In 2003, these
countries agreed to harmonize the requirements for cosmetic products in order to facilitate the
movement of goods and decrease the trade barriers within the region. The new common cosmetics
legislation came into force in 2008. This legislation is called the ASEAN Cosmetic Directive (ACD).
ACD is modelled after the EU Cosmetic Directive and the EU Cosmetic Regulation 1223/2009 that
followed. It is, however, not a complete copy of the EU legislation.

REQUIREMENTS

All products marketed in an ASEAN member country must conform to the provisions of the ACD and
its Annexes and Appendices, including safety, ingredients, labelling, claims requirements and the
good manufacturing practice (GMP) standards.

The ASEAN Cosmetic Directive adopted the list of prohibited and restricted substances, as well as
allowed preservatives, colourants and UV filters from the EU Cosmetic Directive 76/768/EEC and
the regulation that followed. However, not all of the chemicals or ingredients identified in the EU
Cosmetic Regulation Annexes have been transposed to the ACD. For example, fragrance allergens
have intentionally been omitted.

Much like in the EU, each product requires a product information file (PIF) that consists of four
parts: (I) the administrative documents and product summary, (II) quality data of raw materials, (III)
quality data of finished products and (IV) safety and efficacy data. A safety assessment is also part of
the PIF.

Each product placed on the market in the ASEAN needs to have a responsible person that has to
ensure that the product will not cause damage to human health when applied under normal or
reasonably foreseeable conditions of use, has to keep the product information file readily accessible
to the regulatory authority and has to complete the product notification. The company or person
responsible for placing the cosmetic products on the market in each individual ASEAN member
country must be located in that country and must notify the local regulatory authority of that
country. Unlike in the EU, where one notification covers all of the EU countries, in the ASEAN region,
each country requires a separate notification. In keeping with the EU though, there is no pre-market
approval requirement prior to placing products on the market; the emphasis is on post-market
surveillance.

The labelling requirements are also very similar to those in the EU. Labels must be written in English
and/or the national language and/or a language understood by the consumer where the product is
marketed.

Although not a requirement of the ASEAN Cosmetic Directive, Certificates of Free Sale are often
required at ports when cosmetics are imported.

SERVICES OFFERED

• Product classification

• Formula review to ensure compliance with the ASEAN Cosmetic Directive

• Labelling review

• Product Information File preparation

• Safety assessment

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• Certificate of Free Sale

Gulf Cooperation Council

 

APPLICABLE LEGISLATION

The Gulf Cooperation Council (GCC) is a political and economic alliance of Saudi Arabia, Kuwait,
United Arab Emirates, Qatar, Bahrain and Oman. The countries in this alliance share a common
body that is authorized to publish the standards applicable in all of the countries: the GCC
Standardization Organization (GSO). Each country then has a separate local competent authority
that is responsible for enforcing the common standards.

The overall regulatory framework governing cosmetics in the region was finalized and published in
2016. There are three pieces of legislation that cover cosmetic products, each dealing with a
different part of the compliance criteria:

• Safety: GSO 1943/2016: Safety Requirements of Cosmetics and Personal Care Products

• Claims: GSO 2528/2016: Cosmetic products – Technical Regulation of Cosmetic and Personal
Care Product Claims

• GMP: GSO ISO 22716: Good Manufacturing Practices (GMP) – Guidelines on Good
Manufacturing Practices.

REQUIREMENTS

The Gulf Cooperation Council cosmetics legislation closely follows the EU Cosmetics Regulation
1223/2009. However, it has some of its own criteria when it comes to processes, ingredients,
labelling and claims.

 

Products should fulfil certain requirements, some of which are: they should be completely free from
pork and its derivatives, they should be safe for human health under normal and reasonably
foreseeable conditions of use, they should be stable and their properties impacting safety, efficacy
and quality should not change during their shelf life, they should be free from any filthy or
decomposed substances.

 

The legislation is organized in the same way as the EU Regulation when it comes to restricted and
prohibited substances. Annex II lists the prohibited substances, Annex III lists the restricted
substances and Annexes IV to VI list the allowed colourants, preservatives and UV filters—the list of
such ingredients is also very similar to that of the EU.

 

In terms of labelling requirements, it is important to note that the graphics, images and phrases on
the labels should be consistent with Islamic traditions and social values, that certain parts of the
label have to be translated into Arabic and that claims have to be truthful (the legislation on claims
follows the EU common claims criteria).

 

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Despite having the same basic legislation across all of the GCC member countries, each country
requires a separate product notification (Bahrain does not require any notification) and the customs
clearance process requirements may differ from country to country. SERVICES OFFERED

Product classification

Formula review to ensure compliance with the cosmetics legislation

Labelling review

Label translation to Arabic

Compliance with GSO 1943/2016 – product information file preparation

Cosmetic product safety assessment

 

 

 

 

 

 

 

Reference:

1. https://globalregulatorypartners.com/wp-content/uploads/Registration-of-Cosmetics-in-
Brazil-v2-002.pdf

2. Acomprehensivereviewofregulatorrequirementandregistration.pdf
3. https://ceway.eu/international-services/asean/
4. https://ceway.eu/international-services/gcc/
5. Pharmatomarket(postapprovalrequirementinsouthkorea)
6. Associationofsouthwestfast.org
7. https://ceway.eu/international-services/gcc/

 

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