• 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.

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

• Gives an insight into food and food supplements in Indonesia.
• Gives an overview of the governing body and governing regulations.
• Help conduct a basic product compliance for Indonesia market.
• Helps navigate permitted and restricted ingredients.
• Helps understand the product registration pathway.
• Helps understand labelling requirements for food and food supplements.
• Helps validate claims.
• Gives an insight of quality and safety standards.

1. EXECUTIVE SUMMARY
2. LIST OF ABBREVIATIONS
3. QUERIES AND FREYR’S RESPONSES
4. REFERENCES
5. ANNEXURES

• 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

1. LIST OF ABBREVIATIONS
2. INTRODUCTION
3. GOVERNING BODY
4. GOVERNING REGULATIONS
5. DEFINITION
6. INGREDIENTS
7. LOCAL AGENT REQUIREMENTS – RESPONSIBLE PERSON (RP)
   1. Qualification of an RP
   2. Responsibilities of an RP
8. COSMETIC PRODUCT SAFETY REPORT (CPSR)
   1. CPSR’s Content
   2. Safety Assessor’s Qualifications
9. Product Information File (PIF)
10. LABELING
11. ADVERTISING AND CLAIMS
    1. Acceptable Claims
    2. Unacceptable Claims
12. COSMETIC PRODUCT NOTIFICATION
    1. Submit Cosmetic Product Notification (SCPN) Portal
    2. Documents
    3. Submission Mode
    4. Notification Fees
    5. Notification Timeline
    6. Variations
13. 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.

1. LIST OF ABBREVIATIONS
2. GOVERNING BODY
3. GOVERNING REGULATIONS
4. DEFINITION
5. INGREDIENTS
6. LOCAL AGENT REQUIREMENTS – RESPONSIBLE PERSON (RP)
   1. Qualification of an RP
   2. Responsibilities of an RP
7. COSMETIC PRODUCT SAFETY REPORT (CPSR)
   1. CPSR’s content
   2. Safety Assessor’s qualifications
8. PRODUCT INFORMATION FILE (PIF)
9. LABELING
10. ADVERTISING AND CLAIMS
    1. Acceptable Claims
    2. Unacceptable Claims
11. 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
12. 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.

1. List of Abbreviations
2. Governing Regulatory Body
3. Definition and Categorization
4. 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:
5. Renewal (Re-Registration) of Product
   1. General Information for Renewal
   2. Renewal Registration Process
   3. Renewal Registration Timelines
      1. Specialized Expertise
6. Variations
   1. General Information for Variations
   2. Variations Timelines
   3. Change of the Applicant (owner): transfer of rights to the registration certificate
7. Agency Registration Fees and Validity
8. Labelling Requirements
9. Advertising Requirements
10. Pharmacovigilance
11. GMP Recognition or GMP inspection
12. Authorized Representative
13. Import Requirements
14. 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.

List of Abbreviations

1. Regulatory Process
   1. Governing Regulatory Bodies
   2. Laws and Regulations
2. Product Categorization
   1. Definition
3. 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
4. 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.
5. 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
6. 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

• Product definition and classification criteria;
• IVD registration process;
• Precise information on health authority fees, timelines for registration and submission mode (online/in person);
• Additional information on the validity of registration, renewal process and variation filing;
• Details the regulations applicable on the language to be followed;
• Describes the information on requirements of a local agent;

Abbreviations

1. Regulatory Process
   1. Governing Regulatory Bodies
   2. Laws and Regulations
2. Product Categorization
   1. Definition of Medical Device
   2. Classification of Medical Device/Software as Medical Device
3. Registration of SaMD
   1. Registration Procedure
   2. Required Documents
   3. Timeline
   4. Fees
4. Local Representative/ License Holder
   1. Definition of LR/LH
   2. Responsibilities of LR/LH
5. Language requirements
6. QMS requirements

References:

• Provides information on medical devices definition and governing regulatory bodies;
• Details the rules for the classification of medical devices;
• Carefully explains the information on medical devices registration process;
• Highlights the documentation required for different classes of medical devices;
• Precise information on health authority fees and timelines for registration;
• Additional information on the validity of the registration, renewal process and variation filing;
• Details the regulations applicable on the language to be followed;
• Describes the information on requirements of a local agent;

Abbreviations

1. Regulatory Process
   1. Governing Regulatory Bodies
   2. Laws and Regulations
2. Product Categorization
   1. Definition of Medical Device
   2. Classification of Medical Devices
3. Registration of Medical Devices
   1. Registration Procedure for New Application Category
   2. Required Documents
   3. Timeline
   4. Fees
4. Local Representative/ License Holder
   1. Definition of LR/LH
   2. Responsibilities of LR/LH
5. Language requirements
6. QMS requirements
7. References:

• Describe information on Nutritional and Regulatory Claims requirements.
• The report provides queries and Freyr responses.
• The report provides regulatory information about 15 countries.
• Also provide information on Product category: Medicinal Products (OTC & RX) and Food Supplements.

1. Origin
2. Quality (Product)
3. Animal rights
4. Free from….Claims (Product)
5. Sustainability claims
6. References

Across different Markets and Product Categories

• The report provides information on Insights by Region.
• The report provides information on various Insight types.
• The report details on Insights by various product categories.
• Additionally provides information on News alerts/deliverable.

1. Insights by Region
2. Insights by Insight type
3. Insight by Product category
4. News alerts/ Deliverable