Requirements for shipping items that fall under the Cartagena Protocol

I

Imecoli

#1
I hope I didn?t miss this in another section, but i searched with no success. I am looking for any information on the requirements for shipping items that fall under the Cartagena Protocol. We manufacture antibodies and recombinant proteins and we had a question asked by a customer in in Japan who identified the material as falling under the protocol. The material is identified as a recombinant and he is requesting a statement, but I?m unable to find any examples nor do I have any idea of what is required after going through the protocol. any help would be greatly appreciated. we have been selling these material for years over there and have never had this come up.
Thank you in advance,
Matt
 
Elsmar Forum Sponsor
I

Imecoli

#3
Stijloor, thanks for the bump.

It looks like our customer in Japan doesnt even have an example of a statement from another vendor to show me either.
 

Marc

Fully vaccinated are you?
Leader
Admin
#4
For those of us following along: Wikipedia reference-linkCartagena_Protocol_on_Biosafety

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement on biosafety, as a supplement to the Convention on Biological Diversity. The Biosafety Protocol seeks to protect biological diversity from the potential risks posed by genetically modified organisms resulting from modern biotechnology.

The Biosafety Protocol makes clear that products from new technologies must be based on the precautionary principle and allow developing nations to balance public health against economic benefits. It will for example let countries ban imports of a genetically modified organisms if they feel there is not enough scientific evidence that the product is safe and requires exporters to label shipments containing genetically altered commodities such as corn or cotton.

The required number of 50 instruments of ratification/accession/approval/acceptance by countries was reached in May 2003. In accordance with the provisions of its Article 37, the Protocol entered into force on 11 September 2003. The Protocol has 168 parties, which includes 166 United Nations member states, Niue, and the European Union.
http://bch.cbd.int/protocol

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international treaty governing the movements of living modified organisms (LMOs) resulting from modern biotechnology from one country to another. It was adopted on 29 January 2000 as a supplementary agreement to the Convention on Biological Diversity and entered into force on 11 September 2003.
 
Thread starter Similar threads Forum Replies Date
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
J Requirements for Layered Process Audits including Maintenance, Shipping, Receiving IATF 16949 - Automotive Quality Systems Standard 4
S ISO/TS 16949:2009 and Shipping Scale Calibration Requirements IATF 16949 - Automotive Quality Systems Standard 6
R TS Requirements for Warehouses - We store customer owned shipping containers IATF 16949 - Automotive Quality Systems Standard 7
D Overseas Shipping Regulatory Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Automotive Labeling Requirements - B8 & B10 - Creating Compliant Shipping Labels IATF 16949 - Automotive Quality Systems Standard 10
W Statutory and Regulatory requirements - Including Shipping ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Shopfloor drawings & manufacturing requirements Document Control Systems, Procedures, Forms and Templates 2
Sidney Vianna ISO 37301 - Compliance management systems – Requirements with guidance for use Other ISO and International Standards and European Regulations 0
W Insulation requirements of HV pulse circuits IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
C I need some clearing on requirements of Asuring the validity of results ISO 17025 related Discussions 2
S Drawing Requirements for Catalog Items (Class II Medical Device) US Food and Drug Administration (FDA) 3
Sidney Vianna IAF PR 7:2022 - Requirements for Producing IAF Mandatory Documents on Transitions ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
L TGA Requirements Other Medical Device Regulations World-Wide 1
F GM BIQS level 4 requirements Customer and Company Specific Requirements 1
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 2
S Labeling requirements for class 1, fashion sunglasses US Food and Drug Administration (FDA) 0
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
D Organisational chart requirements IATF 16949 - Automotive Quality Systems Standard 5
C Labelling and UDI Requirements - Implications of serial numbers US Medical Device Regulations 1
J Revamping Supplier Qualification, Re-evaluation, and Monitoring Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
M Notification Requirements for Medical Device Raw Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M ISO 20417:2021, Requirements for e-doc 6.6.5 Other Medical Device Related Standards 3
J NMPA translation requirements? China Medical Device Regulations 3
R Labeling requirements for single use devices Manufacturing and Related Processes 4
D "FAI" Requirements/Process for New Supplier Materials Design and Development of Products and Processes 3
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
D 8.5.1.2 Validation and control of special processes requirements for Heat Treat External Processor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D MDR classification and DoC requirements Medical Device and FDA Regulations and Standards News 3
A Mandatory Languages Requirements for Medical Devices CE Marking (Conformité Européene) / CB Scheme 2
R Legacy Device UDI Requirements EU Medical Device Regulations 5
P Customer Specific Requirements (Costco Wholesale) IATF 16949 - Automotive Quality Systems Standard 1
F Self-test minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
H Regarding EMC & Safety retesting requirements of the product CE Marking (Conformité Européene) / CB Scheme 2
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
DuncanGibbons Typical Surface Roughness Requirements for Aviation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Requirements for ANSI Z540.3 Compliance as End User of Calibrated Instruments AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
M Requirements ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 9
Ajit Basrur Any standards relating to ESG requirements? ISO 14001:2015 Specific Discussions 1
D Direct-Marking Requirements under MDR 2017/745 EU Medical Device Regulations 3
D Ford CSR Cpk/Ppk Requirements Statistical Analysis Tools, Techniques and SPC 8
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
E Import requirements in UK? UK Medical Device Regulations 1
R FDA ECG Data Requirements Medical Information Technology, Medical Software and Health Informatics 3
D Locking Control Limits and SPC Sample Sizes (AIAG/Automotive Requirements) Six Sigma 2
M Early feasibility study V&V requirements Design and Development of Products and Processes 1
G Legal & Reg. Requirements - ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
J UDI and Labelling hierarchy and requirements for separate device components EU Medical Device Regulations 7
K Requirements to claim Made in China Other Medical Device Regulations World-Wide 4
A ISO 13485 Calibration Requirements- Assess and Record validity Previous measuring results ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom