Regulatory Reports

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Food and Food Supplements

Regulation of Foods in Nigeria

$450 Request Report

Report

Regulation of Foods in Nigeria

$450

Why should you buy this report?

The report comprises of all necessary information required for the registration of food in Nigeria at NAFDAC. It is an end-to-end report which covers all aspects of a food product life cycle. Revenue in the food market amounts to US$231.50 bn in 2023 and the market is expected to grow annually by 12.75% (CAGR 2023-2028). The objective of this regulatory report is to provide detailed information on food regulations.

Table of contents
Summary

LIST OF ABBREVIATIONS
GOVERNING BODY
GOVERNING REGULATIONS
PRODUCT DEFINITION AND CLASSIFICATION
PRODUCT REGISTRATION
1. Process and Documents
2. Submission Mode
3. Submission Fees
4. Registration Timelines
5. Validity of the Registration
6. Renewal
LOCALLY MANUFACTURED PRODUCTS
LABELING REQUIREMENTS
INGREDIENTS
ADVERTISING
1. Application
2. Documents
3. Timeline
CLAIMS
PROHIBITIONS OR RESTRICTIONS OF CLAIMS ON FOOD PRODUCTS
RESTRICTIONS OR PROHIBITIONS FOR FOOD PRODUCTS
IMPORT REGULATIONS
1. Import Permit
2. Process
3. Documents
CURRENT GOOD MANUFACTURING PRACTICE (cGMP) GUIDELINES FOR FOOD PRODUCTS
VARIATIONS
LOCAL AGENT REQUIREMENTS
CHALLENGES
SURVEILLANCE SYSTEM FOR FOOD PRODUCTS
REFERENCES

Detailed process of registration of food products in Nigeria.
Precise information on documentation, fees, timeline required for submission etc.
References to guidelines.
Labelling and claims regulations.
Local responsible person requirement and responsibilities.
Challenges to enter into the Nigeria market.

Food and Food Supplements

Regulatory Report for Genetically Modified Organism (GMO) Foods Indonesia

$450 Request Report

Report

Cosmetics

Regulatory Report Cosmetics Regulations in UNITED KINGDOM(UK)

$450 Request Report

Report

Regulatory Report Cosmetics Regulations in UNITED KINGDOM(UK)

$450

Why should you buy this report?

This report is a single-point solution to study end-to-end regulations imposed on cosmetic products in the UK. The report aims to provide precise information on the several European Union (EU) guidelines for cosmetic testing, claims support, and many other aspects followed by UK post-BREXIT to enable a Regulatory go-to-market strategy and ensure compliance. Get more insight into the Regulatory landscape and product compliance requirements for the UK cosmetics market in this Regulatory Intelligence Report.

Table of contents
Summary

LIST OF ABBREVIATIONS
INTRODUCTION
GOVERNING BODY
GOVERNING REGULATIONS
DEFINITION
INGREDIENTS
LOCAL AGENT REQUIREMENTS – RESPONSIBLE PERSON (RP)
1. Qualification of an RP
2. Responsibilities of an RP
COSMETIC PRODUCT SAFETY REPORT (CPSR)
1. CPSR’s Content
2. Safety Assessor’s Qualifications
Product Information File (PIF)
LABELING
ADVERTISING AND CLAIMS
1. Acceptable Claims
2. Unacceptable Claims
COSMETIC PRODUCT NOTIFICATION
1. Submit Cosmetic Product Notification (SCPN) Portal
2. Documents
3. Submission Mode
4. Notification Fees
5. Notification Timeline
6. Variations
REFERENCES

Regulatory changes post BREXIT
SCPN product notification process and governing regulations
Precise information on documentation, timelines, fees required for submission, etc.
References to guidelines for allowed and restricted ingredients to check formulation compliance
Labelling requirements and claims regulations
Local responsible person requirements and responsibilities

Cosmetics

Regulatory Report Cosmetics Regulations in European Union (EU)

$450 Request Report

Report

Regulatory Report Cosmetics Regulations in European Union (EU)

$450

Why should you buy this report?

The European cosmetics industry plays a key role in product development which is a science-driven and highly innovative sector. Since the European Union is one of the leading markets in the cosmetics industry, many major players are looking to enter the market with their products.

This comprehensive report provides precise information on cosmetics regulations in the EU, governed by the European Commission, European Parliament and the Council of the European Union. In this Regulatory intelligence report, get insights on the Cosmetics Regulatory landscape and Cosmetics compliance requirements in the EU.

Table of content
Summary

LIST OF ABBREVIATIONS
GOVERNING BODY
GOVERNING REGULATIONS
DEFINITION
INGREDIENTS
LOCAL AGENT REQUIREMENTS – RESPONSIBLE PERSON (RP)
1. Qualification of an RP
2. Responsibilities of an RP
COSMETIC PRODUCT SAFETY REPORT (CPSR)
1. CPSR’s content
2. Safety Assessor’s qualifications
PRODUCT INFORMATION FILE (PIF)
LABELING
ADVERTISING AND CLAIMS
1. Acceptable Claims
2. Unacceptable Claims
COSMETIC PRODUCT NOTIFICATION
1. Cosmetic Product Notification Portal (CPNP)
2. CPNP Access
3. Documents
4. Submission Mode
5. Notification Fees
6. Notification Timeline
7. Variations
REFERENCES

CPNP product notification process and governing regulations;
Precise information on documentation, timelines, fees required for submission, etc.;
References to guidelines for allowed and restricted ingredients to check formulation compliance;
Labeling requirements and claims regulations; and
Local responsible person’s requirements and responsibilities.

Pharmaceuticals

Regulatory intelligence report on registration of drugs in Ukraine

$450 Request Report

Report

Regulatory intelligence report on registration of drugs in Ukraine

$450

Why should you buy this report?

The report comprises all the necessary regulatory information required for the registration of a new medicinal product with the SMDC. The objective of the report is to provide precise information on the Regulatory landscape of Ukraine so that it enables a Regulatory go-to-market strategy and ensures compliance.

Table of content
Summary

List of Abbreviations
Governing Regulatory Body
Definition and Categorization
Registration Requirements
1. Registration Process for a New Medicinal Product
  1. General Information Regarding Registration
  2. Product Registration Process
  3. Product Registration Timelines
2. Requirements for Submission
3. Language Requirements of the Documentation and Correspondence:
Renewal (Re-Registration) of Product
1. General Information for Renewal
2. Renewal Registration Process
3. Renewal Registration Timelines
  1. Specialized Expertise
Variations
1. General Information for Variations
2. Variations Timelines
3. Change of the Applicant (owner): transfer of rights to the registration certificate
Agency Registration Fees and Validity
Labelling Requirements
Advertising Requirements
Pharmacovigilance
GMP Recognition or GMP inspection
Authorized Representative
Import Requirements
REFERENCES

The report details the registration process for a new medicinal product for the SMDC.
The report provides information on labelling (primary and secondary packaging labels) for pharmaceutical products.
The report underlines the regulations levied on imports and also the requirements of a legal representative.
The report provides precise information on health authority fees, along with the timelines and modes of submission.
The report includes information on advertising requirements, pharmacovigilance, and GMP inspection/recognition.
The report provides additional information on the variation fillings and timelines, and the validity of the registration and renewal process.

Pharmaceuticals

Regulatory intelligence report on regulatory landscape for Japan

$450 Request Report

Report

Regulatory intelligence report on regulatory landscape for Japan

$450

Why should you buy this report?

This comprehensive report offers crucial insights into the regulatory landscape of pharmaceutical drugs in Japan. If you’re a pharmaceutical manufacturer or seeking to enter the Japanese market, this report is a valuable resource for understanding the intricacies of drug regulation in Japan.

Table of content
Summary

List of Abbreviations

Regulatory Process
1. Governing Regulatory Bodies
2. Laws and Regulations
Product Categorization
1. Definition
Market Authorization
1. Local Market Authorization Required
2. Market Authorization Process
3. Special Fast-Track (Expedited Pathways) (If applicable)
4. Required Documents for Market Authorizations
5. Approval Timelines
6. Fees for PMDA review
7. Validity of Market Authorization License
Is the Company/Client required to register with the Regulator/ Ministry of Health?
1. Name of Regulator
2. Where and How to Register
3. Does the Company/Client need a physical presence in the country? Are local wholesalers required for distribution?
4. Clarity is required regarding having an office in the country, working with local wholesalers or being able to deliver directly to Hospital pharmacies.
Import/Export Requirements
1. Importing medicines from the Manufacturer into a Company or warehouse in the Netherlands
2. Exporting medicines to Wholesalers from the Company, Warehouse in the Netherlands
3. Examples
PV Reporting Requirements
1. Required Documents for Market Authorizations
2. ADRs to be reported and deadline
3. Reporting Timelines
4. Reporting Format/Mode
5. PSUR/DSUR

References

The report provides information about the regulatory process for pharmaceutical drugs in Japan.
The report details the roles of key regulatory bodies and the approval process.
The report provides a clear understanding of documentation requirements and associated fees.
The report provides information to navigate the Japanese pharmaceutical market.