Compliance in cross border pharmaceutical trade

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Transcript of Compliance in cross border pharmaceutical trade

  • The role of compliance in pharmaceutical cross-border trade
  • Introduction Key Concepts: Globalisation, Global Trade/Cross-Border (Pharmaceutical)Trade Focus on Africa Compliance Trade (General) Pharmaceutical Regulators NAFDAC Nigeria Customs Service Industry (Consumer) Angle Best Practice Summary Remi ADESEUN
  • What is Globalisation? From the Business Perspective: Globalisation is the worldwide movement toward Economic, financial, Trade, and communications integration. 4 Basic Aspects according to IMF: trade and transactions, capital and investment movements, migration and movement of people the dissemination of knowledge.[7] Ref:International Monetary Fund . (2000). "Globalization: Threats or Opportunity." 12th April 2000: IMF Publications.
  • Globalisation: Context & Focus Focus of this Paper: Global Economic Integration or Economic Globalization process by which an increasing share of the economic activity in the world is taking place between people from different countries
  • What is Global Trade? The worldwide business that involves: making and collecting payments for transactions in goods and services, and transporting them to interested markets. Remi ADESEUN
  • Global Trade
  • What is Cross-Border Trade? The buying and selling of goods and services between businesses in neighboring countries, with the seller being in one country and the buyer in the other country, for example, a company in the United States selling to a company in Canada. Or a company in Nigeria selling to a company in Ghana.
  • Cross-Border Trade in Africa One of the biggest obstacles to industrialization in Africa is that African countries trade very little between themselves, only 10-12 percent of total trade, whereas regional trade accounts for 63% in EU, 40% in the US and 30% in Asean countries. Ref: similar/
  • Cross-Border Trade Environment For Pharmaceuticals Key Requirements for Understanding Extensive knowledge of Trade & Customs Practices around the world Deep understanding of import and export laws and regulations, The Global Supply Chain Trade Processes and Controls Extensive knowledge of Pharmaceutical Laws and Regulations Forward-thinking attitude/Global Mindset Harmonisation of Regulatory Requirements
  • Cross-Border Pharmaceutical Trade in Africa Harmonisation of Regulatory Requirements is a key driver for increased intra-regional trade East Africa has made significant progress in this regard by making Product Registration in one Country acceptable for trade in another country Leading to improved Compliance and enhanced Cross-Border Pharmaceutical Trade
  • Key Considerations for Successful Regional Harmonisation in Africa A need to adopt a step-wise approach to harmonisation (e.g Start with Generics) A need to invest in regulatory and industry capacity building, Acknowledgment that NMRAs must follow through on their mandate to promote and protect public health Sustainability, transparency and trust building Use of existing structures and broader REC strategies to advocate for AMRH National sovereignty must be respected, Existing forums should be used to provide regulators with practical advocacy (African Medicines Regulators Conference (AFDRAC), International Conference for Drug Regulatory Authorities (ICDRA), International Conference on Harmonisation Global Cooperation Group (ICH- GCG) Need for the Consortium to keep all stakeholders informed and involved Need to capitalise on strategic niche roles of key players including:WHO, NEPAD, DFID, etc.
  • Industrys Goals Improve Efficiency Harmonisation of Regulatory Requirements Speedier Port Clearance Reduce Cost Mitigate Risk Issues concerning conducting cross-border business
  • What is Trade Compliance Trade compliance is the process by which goods enter into a Country in conformance with all laws and regulations of that Country. It should be the goal of the Customs Service to maximize trade compliance while facilitating the importation of legitimate cargo.
  • Drivers of Increased Compliance Focus in Cross-Border Pharmaceutical Trade tremendous increase in international trade and transport, the growing awareness of trans- national organized crime and, more recently, the threat of terrorism. increased awareness in Customs administrations that national and and international co-operation is essential
  • Pharmaceutical Regulatory Aspects of Compliance in Cross-Border Pharmaceutical Trade Pharmacy & Drug Laws NAFDAC Act, Cap N1 LFN 2004 (formerly Decree 15 of 1993 as amended) + 14 Subsidiary Regulations Drugs and Related Products (Registration, etc) Act Cap F33 LFN 2004 (Formerly Decree 19 of 1993 (as amended) Pharmacists Council of Nigeria (PCN) Act 91 of 1992 Food and Drugs Act Cap 150 LFN (as amended) National Drug Formulary and Essential Drugs List Act Cap 252 LFN 1990 Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Cap 34 LFN 2004 (formerly Decree 25 of 1999) Poisons and Pharmacy Act (PPA) Cap 535 LFN 1990 Dangerous Drugs Act (DDA) Cap 91 LFN 1990 NDLEA Act of 1989 Remi ADESEUN
  • NAFDAC MANDATE NAFDAC was established by Decree No. 15 of 1993 (now NAFDAC Act CAP N1 LFN, 2004) to Regulate and Control the Importation, Exportation, manufacture, distribution, advertisement, sale and use of Foods, Drugs, Cosmetics, Medical Devices, Chemicals, Detergents and packaged water. This mandate places on Ports Inspection Directorate (PID) the responsibility of carrying out the following functions and exercising powers as described in sections 5d,5e and 5g of the NAFDAC Act.
  • NAFDAC Act CAP N1 LFN, 2004 5d) undertake inspection of imported food, drugs, cosmetics, medical devices, bottled water and chemicals and establish relevant quality assurance systems, including certification of the production sites and of the regulated products; 5e) compile standard specifications and guidelines for the production, importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water and chemicals; 5g) control the exportation and issue quality certification of food, drugs, cosmetics, medical devices, bottled water and chemicals intended for export. NAFDAC
  • NAFDAC controls the importation and exportation of all the products covered by this Act at the Sea Ports, Airports and Land borders. No NAFDAC regulated product shall be imported into and exported out of Nigeria unless it has been duly registered and/or issued a permit or certificate in accordance with the provisions of Act Cap F33 LFN 2004 and the accompanying guidelines. NAFDAC
  • To control and inspect imported food, drugs, cosmetics, medical devices, and chemicals at ports of entry. To control the export of food, drugs, cosmetics, medical devices, and chemicals and issue quality certification of the above products for export. Duties also include compilation of guidelines & regulation for importation/exportation of regulated products. Collaborate with other relevant Agencies, Organizations and the Private Sector at the Ports and Land Borders. Sampling of relevant products for lab analysis before final release Implementation of Government fiscal policy on the prohibition of imports of regulated products through the ports and land borders. NAFDAC: Functions
  • Imposition of sanctions and administrative penalties for violations including outright seizures for violative products and apprehension of culprits. Operation of 24-hour surveillance at designated airports. Organizing seminars, workshops and meetings to sensitize, update and create awareness on NAFDAC regulations as it concerns imports and exports. Holding Consultative meetings with sectoral groups and stakeholders to encourage regulatory compliance. NAFDAC: Functions
  • A.) IMPORTS: The divisions in PID ensure proper documentation and endorsement of customs documents during importation. The Ports (sea and Air) and Land border offices conduct physical inspection of goods, Hold assignments, fast track activities and final release of goods at the various ports and land borders. Import Activities occur as: Pre-clearance Activities Clearance Activities Post Clearance Activities NAFDAC: Operations
  • B.) EXPORTS: NAFDAC mandate covers the certification of finished pharmaceutical products that are meant for export. The following Certificates are issued on satisfying the requirements for export: Combined Certificate of manufacture and free sale (for registered