YOUR COMPLIANCE JOURNEY FOR COSMETICS TO GET CPNP NUMBERS
Get familiar with the steps & timeline!
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1. Your RA consultant will send you Annex A – List of products.
2. Customer Relations dept. will share the Order Form to cover compliance process.
3. Accounting dept. will share with you the related invoice.
PRE-COMPLIANCE PROCESS
What will Obelis do?
1. To fully complete & sign & send back Annex A to Obelis.
2. Carefully review the Order Form & add signature & send it back to Obelis.
3. Settle the payment of the invoice.
What we need from you?
1. Send you instructions letter on the needed documentation.
2. Grant access to the online Repository
3. Review your documentation as per applicable regulatory requirements.
4. Provide feedback on your documentation.
5. Submit the PIF to the Safety Assessor to issue a Safety Assessment Report (SAR).
*Issuance of the SAR can take several weeks, depending on the service selected.
COLLECTION OF NECESSARY DOCUMENTATION
What will Obelis RA consultant do?
What we need from you?
1. To upload all the necessary documentation to the Repository.
- Watch a short video how to navigate the Repository
2. Inform us once the upload of the documentation is complete.
3. Provide updated documentation implementing feedback given by your RA consultant.
1. Notify your product to the relevant portal.
- Obelis officially becomes the Responsible Person for this product.
2. Send you notification numbers (CPNP, SCPN).
NOTIFICATION OF YOUR PRODUCT(S)
What will Obelis RA consultant do?
1. Send you Certificates’ specimens for review.
2. Upon confirmation, send you finalized Certificates per email.
OBELIS CERTIFICATE ISSUANCE
What will Obelis RA consultant do?
What we need from you?
1. Review specimens & confirm the information.
1. Remain available for any questions, queries.
2. Send you regulatory updates through COSlaw.
ACCESS TO THE MARKET
What will Obelis RA consultant do?
What you need to do?
1. Translate your labels & IFUs – when applicable.
2. Inform us of any changes to your documentation.
1. Your RA consultant will send RP Mandate template to your importer(s)
2. Obelis CEO will sign the RP Mandate to release the importers of RP responsibility.
RP MANDATE ISSUANCE
What will Obelis do?
What you need to do?
1. Translate your labels & IFUs – when applicable.
2. Inform us of any changes to your documentation.
STEP 1
STEP 2
STEP 3
STEP 4
STEP 5
STEP 6
Not sure about your process?
Obelis Group
Boulevard Brand Whitlock 30, Brussels, 1200, Belgium
Tel: +3227325954
Fax: +3227326003
sales@obelis.net
© Obelis Group 2023
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