legally binded
Compliance with Regulations In The European Union
REACH/ECHA, the EU legislation covering the manufacturing and importation of chemicals, became law in 2007. A number of substances were registered under REACH in 2012. The next batch of substance registrations is due in 2013. Over the next five and one half years, the number of registrations will increase significantly. Additionally, the amount of products imported or manufactured must be monitored and more information must be passed along the supply chain. The costs to comply with REACH depend on the behavior of the other participants in the supply chain. So far, the costs have not been greater than what we expected. The GHS is altering the rules for classification, labeling and, to some extent, the content of our MSDSs. In 2012 the system was implemented in the U.S. Countries in Asia and South America will follow soon. All hazardous products in our product portfolio will be affected and have to be reclassified.
Compliance Commitment
Compromised with highest standards
ND Pharma & Biotech Co. is committed to the highest standards of corporate compliance and business integrity, and adherence to all applicable laws and regulations and industry codes in every country and territory where company is operating. Our commitment extends to all company interactions with investors and customers, including healthcare professionals, patients, healthcare organizations, and patient advocacy groups.
All ND Pharma & Biotech and Company employees are expected to share in and contribute to ND Pharma & Biotech’s commitment to compliance by participating in training, and performing all tasks with integrity and in a manner consistent with ND Pharma & Biotech’s policies and procedures. Our compliance program incorporates elements in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the United States Department of Health and Human Services, Office of Inspector General, is consistent with the Pharma Code , and includes an Open Door Policy.
complex regulatory environments
In The United States of America
The Company believes that it is in compliance in all material respects with federal, state and local regulations relating to the manufacture, sale and distribution of its products. The following are brief summaries of some of the federal, national, territorial and other existing laws and regulations which may have an impact on the Company’s business. These summaries are only illustrative of the extensive regulatory requirements of federal, state and local governments and are not intended to provide the specific details of each law or regulation. The Company intends to maintain compliance with existing laws within all territories and countries where is maintaining operations.
Global Business Compliance
As a Global Company we comply with Regulations…
The Company also conducts its global business in compliance with or analogous to the following statutes and regulations as promulgated in the more than 50 countries into which we sell our products.
For more information, please visit our commercial website:
www.ndpharmabiotech.net.
Reporting Potential Compliance Violations
If you see or suspect activity that is in violation of ND Pharma & Biotech’s commitment to compliance or its specific policies and procedures, please report it. Reports or complaints about potential compliance violations may be submitted through the following channel:
(i) our Compliance Email Box at compliance@ndpharmabiotech.com.
Or contacting our Chief Compliance Officer.
J. P. Rutherford
ndpharmabiotech@europe.com
Ref: Compliance Violation Report..