Farmatec
Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry.
Farmatec is a Dutch organization that provides essential services for the registration and approval of medical devices and medicinal products. They assist the pharmaceutical industry by obtaining necessary permits, approvals, and Free Sales Certificates. Operating from Den Haag, Farmatec is part of the CIBG agency. They offer guidance and support for various regulatory processes, including those related to medicinal products, medical devices, and in-vitro diagnostics (IVDs). Farmatec's services are crucial for companies navigating the complex regulatory landscape in the Netherlands and potentially the EU. Their expertise ensures compliance and facilitates market access for a wide range of healthcare products. They can be contacted via email, telephone, or postal mail for inquiries and support.
About
**Who they are**
Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry. They are part of the CIBG agency.
**Expertise & scope**
* Registration and approval of medical devices and medicinal products
* Services for permits and Free Sales Certificates
* Support for Add-on medicins
* Assistance with Certificate of a Pharmaceutical Product (CPP)
* Handling registrations for medical devices and in-vitro diagnostics (IVD's)
* Support for Pharmaceutical Permits and Exemptions (V&O)
* Guidance on Import and Export opium law resources
* Assistance with Maximum prices medicines
* Support for Online providers medicines
* Services for Reimbursement of medicines
**Reputation / proof points**
* Operates within the EU
Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry. They are part of the CIBG agency.
**Expertise & scope**
* Registration and approval of medical devices and medicinal products
* Services for permits and Free Sales Certificates
* Support for Add-on medicins
* Assistance with Certificate of a Pharmaceutical Product (CPP)
* Handling registrations for medical devices and in-vitro diagnostics (IVD's)
* Support for Pharmaceutical Permits and Exemptions (V&O)
* Guidance on Import and Export opium law resources
* Assistance with Maximum prices medicines
* Support for Online providers medicines
* Services for Reimbursement of medicines
**Reputation / proof points**
* Operates within the EU
Additional information
Farmatec provides contact information for various specialized services related to pharmaceutical products and medical devices. These include dedicated email addresses and phone numbers for specific areas such as Add-on medicins, Certificate of a Pharmaceutical Product (CPP), Free sales certificates and registrations for medical devices and in-vitro diagnostics (IVD's), Pharmaceutical Permits and Exemptions (V&O), Import and Export opium law resources, Maximum prices medicines, Online providers medicines, and Reimbursement of medicines. They also outline a process for handling complaints, directing unsatisfied clients to first discuss issues with the concerned employee or manager, and then to the CIBG agency if the matter is not resolved.
Key Highlights
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Specializes in the registration and approval of medical devices and medicinal products.
Source
“Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry.”
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Offers services for permits and Free Sales Certificates.
Source
“Farmatec specializes in the registration and approval of medical devices and medicinal products, offering services for permits and Free Sales Certificates within the pharmaceutical industry.”
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Provides support for a wide range of specific regulatory areas including IVD's, CPP, and pharmaceutical permits.
Source
“Free sales certificates and registrations medical devices and in-vitro diagnostics (IVD's) Certificate of a Pharmaceutical Product (CPP) Pharmaceutical Permits and Exemptions (V&O)”
Certifications & Trust Signals
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Farmatec is part of the CIBG agency.
Source
“Farmatec is part of the CIBG agency.”
Buyer Snapshot
Best for
- Companies seeking registration and approval for medical devices and medicinal products
- Businesses requiring permits and Free Sales Certificates
How engagement typically works
- Direct consultation via email and telephone
- Structured complaint resolution process
Typical deliverables
- Registration support for medical devices and medicinal products
- Permits and Free Sales Certificates
- Assistance with specific product registrations (e.g., CPP, IVD's)
Good to know
- Best when requiring specialized support within the pharmaceutical and medical device sectors.
HQ:
Den Haag, NL
Languages:
English
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
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Jurisdictions:
EU
Countries:
DE, DK, IT, BE, FR, ES
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–21 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 2,500
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
No
Modules Supported:
Actor/SRN, UDI/Devices, Certificates
Supports Training Enablement:
No
Data Load Support Level:
Training only
Turnaround SLA:
Custom
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
No explicit mention of onboarding steps, but contact information for specific services is provided.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
UDI/Devices, Certificates & Notifications
Supports Actor Registration
No explicit mention
Supports UDI
Yes, for medical devices and in-vitro diagnostics (IVD's)
Supports Vigilance
No explicit mention
Supports Clinical Investigations
No explicit mention
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