Discuss The Placement Strategy You Plan To Recommend

Discuss The Placement Strategy Which You Plan To Recommend For Your Ex

Discuss the placement strategy which you plan to recommend for your Export Market Strategy Report. Be sure to remind the class what product or service you are looking to export. Product and country Who are the end-users? Where do they buy the product? How does the product get from your US-based facility to the end-user? Who holds and is responsible for the product in each step of the supply chain? What logistics or supply chain issues are there with exporting the product or service which you are examining? What market entry method will you use for each segment in the target country? Include agreement terms with other companies e.g., agents, distributors Are there any EU approvals for your client and how they can get these approvals? Do you package the insulin in zip closing bags in the US? Are a number of these bags put in a shipping box? Does the US require an export license for insulin? Be sure to refer to Chap 6-8, 13 in your textbook Albaum, G. (2011). International marketing and export management (7th ed). Prentice-Hall

Paper For Above instruction

In developing an effective placement strategy for exporting insulin from the United States to the European Union (EU), a comprehensive understanding of the product, target market, supply chain logistics, and regulatory requirements is essential. The selected product for this export strategy is insulin, a vital pharmaceutical product used by individuals with diabetes. The targeted export markets are primarily key EU countries with high diabetes prevalence, including Germany, France, and the United Kingdom.

Target End-Users and Purchasing Locations

The end-users of the insulin are individuals diagnosed with diabetes, requiring regular insulin injections to regulate their blood glucose levels. These consumers typically purchase insulin through pharmacies, hospital clinics, and authorized healthcare providers. In many cases, they acquire it directly from pharmacy chains or healthcare clinics that stock the product as part of their diabetes management programs. The purchasing process often involves prescriptions provided by licensed medical practitioners, ensuring safety and regulatory compliance.

Supply Chain and Logistics

The logistics of delivering insulin from a US-based manufacturing facility to European end-users involve several critical steps. Initially, insulin is produced at the manufacturing plant domestically in the US and then packaged. In the US, insulin is often packaged in zip-closure bags, contained within secure, refrigerated shipping boxes to maintain the required cold chain during transit. These insulated boxes are designed to keep the insulin at appropriate temperatures throughout the journey, which can range from several days to weeks, depending on the destination.

The responsibility for the product shifts at various points along the supply chain. The manufacturer holds responsibility until the product is shipped out, after which logistics service providers and customs authorities oversee transportation. Once the insulin arrives in the EU, local distributors and pharmacies assume responsibility for storage, retailing, and dispensing to end-users. Maintaining the cold chain during the entire process is crucial, and any breach could compromise product efficacy and safety.

Logistics and Supply Chain Challenges

The primary logistical challenge is ensuring strict cold chain management to prevent quality degradation of insulin, which is temperature-sensitive. The transportation process involves refrigerated shipping containers, real-time temperature monitoring, and compliance with international standards. Customs clearance also poses potential delays due to regulatory differences, requiring proactive preparation for documentation and inspections. Additionally, variations in export and import licensing, tariffs, and customs procedures can impact shipping costs and delivery timelines.

Market Entry Strategy and Agreements

Regarding market entry, the recommended approach is establishing partnerships with local distributors and pharmacy chains through contractual agreements. Utilizing agents or independent distributors enables market penetration without investing heavily in infrastructure. These partners will be responsible for distribution, storage, and sales within their respective countries, under agreed-upon terms concerning pricing, responsibilities, and compliance with local regulations. Distribution agreements should specify that local partners adhere to EU regulations and standards, including Good Distribution Practice (GDP).

EU approval for insulin involves compliance with European Medicines Agency (EMA) regulations. Gaining approval requires submitting comprehensive dossiers demonstrating safety, efficacy, and manufacturing standards. This process is facilitated if the insulin product has prior approval from the US Food and Drug Administration (FDA) and can be supported by mutual recognition agreements between the US and EU. In some cases, additional local testing or certification may be needed.

Product packaging in the US involves placing insulin vials or pens into zip-closure bags, which are then grouped into shipping boxes designed for cold chain transportation. The US does not require an export license specifically for insulin, but appropriate documentation, including export declaration forms and certificates of compliance, must be prepared under the US Bureau of Industry and Security (BIS) regulations.

In conclusion, a successful placement strategy for exporting insulin to the EU hinges on meticulous planning of logistics, regulatory compliance, and establishing reliable local partnerships. Maintaining temperature integrity throughout the supply chain and securing necessary approvals will ensure the safety and availability of insulin for EU consumers, ultimately supporting the overarching goal of expanding US pharmaceutical exports into European markets.

References

  • Albaum, G. (2011). International marketing and export management (7th ed.). Prentice-Hall.
  • European Medicines Agency. (2023). Regulatory requirements for medicines. https://www.ema.europa.eu
  • U.S. Department of Commerce. (2022). Export regulations and licensing. https://www.trade.gov
  • FDA. (2023). Regulatory requirements for pharmaceuticals. https://www.fda.gov
  • United Parcel Service. (2023). Cold chain logistics for pharmaceuticals. https://www.ups.com
  • World Health Organization. (2022). Diabetes management and insulin use. https://www.who.int
  • European Commission. (2022). Guidelines for pharmaceutical packaging. https://ec.europa.eu
  • United States Patent and Trademark Office. (2023). Intellectual property considerations in pharmaceuticals. https://www.uspto.gov
  • Customs and Border Protection. (2023). Import and export documentation requirements. https://www.cbp.gov
  • Global Cold Chain Logistics. (2022). Best practices in temperature-sensitive shipping. https://www.globalcoldchain.com

Related Assignments