100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
RAC DRUGS LATEST 2023 ALREADY PASSED $9.99   Add to cart

Exam (elaborations)

RAC DRUGS LATEST 2023 ALREADY PASSED

 37 views  1 purchase
  • Course
  • RAC DRUGS
  • Institution
  • RAC DRUGS

RAC DRUGS LATEST 2023 ALREADY PASSED (EU) MA Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA National, centralised, mutual recognition, decentralized procedures MAH A legal person or legal entity who m...

[Show more]

Preview 2 out of 6  pages

  • September 17, 2023
  • 6
  • 2023/2024
  • Exam (elaborations)
  • Questions & answers
  • RAC DRUGS
  • RAC DRUGS
avatar-seller
StellarScores
RAC DRUGS LATEST 2023 ALREADY PASSED (EU) MA ✔✔Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA ✔✔National, centralised, mutual recognition, decentralized procedures MAH ✔✔A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? ✔✔Active substance international non -proprietary name, trade name. SmPC ✔✔Summary of Product Characteristics PIL ✔✔Product Information Leaflet 6 months ✔✔How many months prior to expiration should MA renewal be submitted? Qualified Person (QP) in charge of ? ✔✔Pharmacovigilance, scientific service in charge of each medicinal products scientific info ASMF ✔✔Active Substance Master File, info regarding the drug substance consists of one Applicants Part (AP), and one Restricted Part (RP), or proprietary inform ation. CEP ✔✔Certificate of Suitability EDQM ✔✔European Directory for the Quality of Medicines CTD Module 1 ✔✔Region specific administrative data CTD Module 2 ✔✔Quality Overall Summary CTD Module 3 ✔✔Drug Substance and Drug Product Information

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

Guaranteed quality through customer reviews

Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.

Quick and easy check-out

Quick and easy check-out

You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.

Focus on what matters

Focus on what matters

Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!

Frequently asked questions

What do I get when I buy this document?

You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.

Satisfaction guarantee: how does it work?

Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.

Who am I buying these notes from?

Stuvia is a marketplace, so you are not buying this document from us, but from seller StellarScores. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $9.99. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

78998 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$9.99  1x  sold
  • (0)
  Add to cart