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Selling into Europe as a packaging and machinery supplier from the United States
Avoid costly import delays and secure your European pharmaceutical machinery contracts.
The moment it goes wrong
A misclassified Harmonized System code for your packaging line can halt an entire shipment at a German port. This leads to unexpected storage fees and jeopardizes your client's production schedule, costing thousands in lost revenue and damaging your reputation.
What changes after this course
Your sales team will confidently discuss European regulatory compliance and customs procedures. They will accurately prepare quotes considering duties, taxes, and certification requirements. You will receive a comprehensive training record for your internal quality management system.
How long it takes, by who is listening
Nobody spends a day in a classroom. Every module exists in three lengths; a person takes the length their role needs, and every length ends with the same recorded questionnaire, so the training record is complete either way.
| Who takes this course | Length | Total time |
|---|---|---|
| Owner, CEO and board | Briefing | 2 h |
| Business development and export sales | Briefing | 2 h |
| Regulatory affairs | Standard | 5 h |
| Quality assurance and Qualified Person | Standard | 5 h |
What is in the course, module by module
12 modules. Under each title are the three things the listener can do afterwards; the audio itself runs 10 to 50 minutes depending on the length chosen. Each module ends with a multiple-choice questionnaire whose result is recorded per person for your auditor. Your human-resources or quality manager decides what counts as passed and when a level is retaken.
1Understand Europe's Pharmaceutical Market and Regulatory Environment
- Grasp the structure of the European Union and its common market for goods.
- Identify key European regulatory bodies impacting pharmaceutical suppliers.
- Recognize the general principles of EudraLex Volume 4 Good Manufacturing Practice (GMP).
2Apply Medical Device and Machinery Directives to Your Products
- Learn if your packaging machinery falls under the Medical Device Regulation (MDR) 2017/745.
- Determine how the In Vitro Diagnostic Regulation (IVDR) 2017/746 might apply to your equipment.
- Understand the essential health and safety requirements of the Machinery Directive 2006/42/EC.
3Achieve CE Marking for European Market Entry
- Identify the conformity assessment procedure required for your specific product type.
- Understand the role of Notified Bodies in the CE marking process for certain devices.
- Prepare the necessary technical documentation file to demonstrate conformity.
4Master European Customs Codes and Import Tariffs
- Accurately assign Harmonized System (HS) codes to your pharmaceutical packaging and machinery products.
- Calculate the applicable import duties and tariffs based on the correct HS classification.
- Understand the importance of obtaining an Economic Operators Registration and Identification (EORI) number.
5Plan Effective Logistics and Shipping Strategies for Europe
- Select the appropriate Incoterms 2020 for your international sales contracts.
- Identify reliable freight forwarders experienced in shipping to European Union countries.
- Understand the documentation required for smooth customs clearance, such as the Commercial Invoice.
6Calculate Pricing with European Value Added Tax (VAT) and Duties
- Learn how Value Added Tax (VAT) applies to goods imported into and sold within the European Union.
- Accurately incorporate customs duties and VAT into your final pricing for European clients.
- Understand the process for VAT registration if your company needs to collect and remit VAT.
7Structure Your European Sales Contracts and Legal Terms
- Identify key clauses specific to European contracts, including jurisdiction and governing law.
- Understand the role of an Authorized Representative for certain regulated products in Europe.
- Recognize the cost of poorly defined warranty and liability terms in European agreements.
8Manage Post-Market Surveillance and After-Sales Support
- Understand your obligations for post-market surveillance under European regulations.
- Develop a strategy for providing technical support and spare parts to European customers.
- Learn about product recall procedures and reporting requirements to European authorities.
9Adapt to European Business Culture and Communication Styles
- Identify common business etiquette practices when interacting with European clients.
- Understand the importance of direct and precise communication in European business dealings.
- Recognize cultural nuances that can impact negotiations and long-term relationships.
10Identify and Qualify European Distribution Partners
- Develop criteria for selecting effective distributors or agents within the European market.
- Understand the legal implications of different types of distribution agreements.
- Learn how to conduct due diligence on potential European partners to mitigate risks.
11Avoid Common Pitfalls in European Market Entry
- Recognize the mistake of underestimating regulatory compliance costs and timelines.
- Understand the financial impact of incorrect product labeling and documentation.
- Learn to prevent delays caused by incomplete or inaccurate customs declarations.
12Develop a Comprehensive European Market Entry Plan
- Outline the critical steps for successfully introducing your products to the European market.
- Create a checklist for regulatory compliance, logistics, and sales strategy.
- Prepare a summary of key decisions for your internal stakeholders regarding European expansion.
Price for this title
One licence, 12 modules in all three lengths, included in every purchase, every employee of the legal entity, 12 months. Pick your company size.
Cheaper as part of a track pack or company library. Delivered within 72 hours of payment or the course is free.
Custom course or custom pricing? A course built on your own procedures and products, a mixed bundle, several legal entities, or a budget that does not fit a table: tell us on WhatsApp and you have a written quote the same day.
Ask about custom courses and custom pricingWho this is for
Roles: Owner, CEO and board, Business development and export sales, Regulatory affairs, Quality assurance and Qualified Person,
Businesses: Packaging and machinery supplier,
Countries: United States
What you receive
- Audio modules in all three lengths, included in every purchase. The briefing for the board and the sales floor, the standard run for regulatory and quality, the expanded walk-through for the bench. One price buys all three; each person takes the length their role needs. Listen on the commute, at the bench, in the car.
- Made to be listened to. A narrator with character, a story in every module and real examples from the buyer's side of the table. Not a read-out of the guideline that puts the room to sleep.
- Companion workbook. Exercises and checklists per module, ready to file.
- Full transcript. Searchable, printable, quotable in your procedures.
- Source for every fact. Each statement links to its guideline, regulation or paper, so an auditor can check it.
- Certificate per learner. Name, course, hours, guideline version, date.
- Auditable training record. Per-person export for your quality file, the document inspectors ask for under EU GMP Chapter 2.
English first. Other languages are available in test mode on request.
Request a free sample module