Regulatory Open Forum

Hello all,
I am looking for some clarification on the qualifications of QP (Qualified Person)  in EU Member States.

The Article 49 of the Directive 2001/83 (a link to the directive here) outlines the qualifications and necessary experience to become a QP. The part of the Article reads: 
"A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology."

After reviewing this Directive, I came up with the following question:
1)  Is a "diploma or certificate of qualifications" received from Non-EU Member States, to say, in Republic of Korea (e.g. a registered pharmacist in Korea), acceptable/qualified?
2)  Does each Member State have different Qualification process for QP? Is there an exam to complete to become a registed/qualified QP?

I would appreciate any comments/directions.
Thank you in advance for your help.

-------------------------------------------
Dahuin Liz Lee
Seoul
Korea, Republic of
-------------------------------------------

Dear Dahuin

Becoming a QP in the EU is based on the directive you mention. However, member states can add further requirements and that they do. Thus, the requirements differ for (nearly) each member state. For example, in the UK being a chartered biologist, chemist or pharmacist makes you eligible to become a QP. Germany will hardly ever accept anyone who isn't a pharmacist. In Italy you must be employed by the company for which you  act as a QP. In the UK you can work as an independent QP. Some countries even require you to reside within the country in which you are registered (although this violates other EU directives).

Depending on the member state the rules for accepting a non-EU certification differ. Typically, a PhD is likely to be equivalent, other grades maybe not. In many cases additional training courses may be required, and yes a certification exam (in the national language) is the norm.
You also need to understand what type of products you will be able to release based on your training and more importantly, practical experience: e.g. investigational medicinal products, sterile aseptic products, solid dosage forms, biologicals.

In the UK at least you can find more information from the Royal Society of Chemistry (www.rsc.org)

Siegfried

-------------------------------------------
Siegfried Schmitt, FRSC CChem CSci
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
-------------------------------------------






Original Message:
Sent: 04-16-2014 05:20
From: Dahuin Lee
Subject: QP(Qualified Person) Qualification

Hello all,
I am looking for some clarification on the qualifications of QP (Qualified Person)  in EU Member States.

The Article 49 of the Directive 2001/83 (a link to the directive here) outlines the qualifications and necessary experience to become a QP. The part of the Article reads: 
"A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology."

After reviewing this Directive, I came up with the following question:
1)  Is a "diploma or certificate of qualifications" received from Non-EU Member States, to say, in Republic of Korea (e.g. a registered pharmacist in Korea), acceptable/qualified?
2)  Does each Member State have different Qualification process for QP? Is there an exam to complete to become a registed/qualified QP?

I would appreciate any comments/directions.
Thank you in advance for your help.

-------------------------------------------
Dahuin Liz Lee
Seoul
Korea, Republic of
-------------------------------------------

Dear Siegfried,
Your response was extremely helpful!
I am about to explore the link you've posted here also.
Thank you again for your help.


Sincerely,

-------------------------------------------
Dahuin Lee
Seoul
Korea, Republic of
-------------------------------------------






Original Message:
Sent: 04-17-2014 02:38
From: Siegfried Schmitt
Subject: QP(Qualified Person) Qualification

Dear Dahuin

Becoming a QP in the EU is based on the directive you mention. However, member states can add further requirements and that they do. Thus, the requirements differ for (nearly) each member state. For example, in the UK being a chartered biologist, chemist or pharmacist makes you eligible to become a QP. Germany will hardly ever accept anyone who isn't a pharmacist. In Italy you must be employed by the company for which you  act as a QP. In the UK you can work as an independent QP. Some countries even require you to reside within the country in which you are registered (although this violates other EU directives).

Depending on the member state the rules for accepting a non-EU certification differ. Typically, a PhD is likely to be equivalent, other grades maybe not. In many cases additional training courses may be required, and yes a certification exam (in the national language) is the norm.
You also need to understand what type of products you will be able to release based on your training and more importantly, practical experience: e.g. investigational medicinal products, sterile aseptic products, solid dosage forms, biologicals.

In the UK at least you can find more information from the Royal Society of Chemistry (www.rsc.org)

Siegfried

-------------------------------------------
Siegfried Schmitt, FRSC CChem CSci
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
-------------------------------------------






Original Message:
Sent: 04-16-2014 05:20
From: Dahuin Lee
Subject: QP(Qualified Person) Qualification

Hello all,
I am looking for some clarification on the qualifications of QP (Qualified Person)  in EU Member States.

The Article 49 of the Directive 2001/83 (a link to the directive here) outlines the qualifications and necessary experience to become a QP. The part of the Article reads: 
"A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology."

After reviewing this Directive, I came up with the following question:
1)  Is a "diploma or certificate of qualifications" received from Non-EU Member States, to say, in Republic of Korea (e.g. a registered pharmacist in Korea), acceptable/qualified?
2)  Does each Member State have different Qualification process for QP? Is there an exam to complete to become a registed/qualified QP?

I would appreciate any comments/directions.
Thank you in advance for your help.

-------------------------------------------
Dahuin Liz Lee
Seoul
Korea, Republic of
-------------------------------------------

one more link http://www.qp-association.eu/qpag_regulations.html

-------------------------------------------
Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
-------------------------------------------






Original Message:
Sent: 04-16-2014 05:20
From: Dahuin Lee
Subject: QP(Qualified Person) Qualification

Hello all,
I am looking for some clarification on the qualifications of QP (Qualified Person)  in EU Member States.

The Article 49 of the Directive 2001/83 (a link to the directive here) outlines the qualifications and necessary experience to become a QP. The part of the Article reads: 
"A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology."

After reviewing this Directive, I came up with the following question:
1)  Is a "diploma or certificate of qualifications" received from Non-EU Member States, to say, in Republic of Korea (e.g. a registered pharmacist in Korea), acceptable/qualified?
2)  Does each Member State have different Qualification process for QP? Is there an exam to complete to become a registed/qualified QP?

I would appreciate any comments/directions.
Thank you in advance for your help.

-------------------------------------------
Dahuin Liz Lee
Seoul
Korea, Republic of
-------------------------------------------

Mr. Lee,

Pursuant to 2001/82/EC or 2001/83/EC, it should be interpreted as "it is up to a manufacture to ensure the eligibility and suitability of a QP in their marketing application."

You may want to read my post here. 

I am using an example from UK MHRA (competent authority).  

-------------------------------------------
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------






Original Message:
Sent: 04-16-2014 05:20
From: Dahuin Lee
Subject: QP(Qualified Person) Qualification

Hello all,
I am looking for some clarification on the qualifications of QP (Qualified Person)  in EU Member States.

The Article 49 of the Directive 2001/83 (a link to the directive here) outlines the qualifications and necessary experience to become a QP. The part of the Article reads: 
"A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology."

After reviewing this Directive, I came up with the following question:
1)  Is a "diploma or certificate of qualifications" received from Non-EU Member States, to say, in Republic of Korea (e.g. a registered pharmacist in Korea), acceptable/qualified?
2)  Does each Member State have different Qualification process for QP? Is there an exam to complete to become a registed/qualified QP?

I would appreciate any comments/directions.
Thank you in advance for your help.

-------------------------------------------
Dahuin Liz Lee
Seoul
Korea, Republic of
-------------------------------------------

Dear Chang

Though you are correct that a marketing authorisation holder needs to ascertain if a QP is suitable for their needs, it is the regulatory authority, which ultimately approves or not.
In fact, the MHRA is one authority, which has not approved certain individuals, which were named on too many applications for them to be able to carry out their duties in accordance with the regulations.

As an aside: I followed your link and I noticed mention of the orange guide. There is a much more current version available: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 - the 'Orange Guide' at www.mhra.gov.uk
Though all contents can also be accessed for free on the internet. This merely is a convenient compilation

Regards
Siegfried

-------------------------------------------
Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
-------------------------------------------






Original Message:
Sent: 04-26-2014 16:34
From: Chang Lim
Subject: QP(Qualified Person) Qualification

Mr. Lee,

Pursuant to 2001/82/EC or 2001/83/EC, it should be interpreted as "it is up to a manufacture to ensure the eligibility and suitability of a QP in their marketing application."

You may want to read my post here. 

I am using an example from UK MHRA (competent authority).  

-------------------------------------------
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------






Original Message:
Sent: 04-16-2014 05:20
From: Dahuin Lee
Subject: QP(Qualified Person) Qualification

Hello all,
I am looking for some clarification on the qualifications of QP (Qualified Person)  in EU Member States.

The Article 49 of the Directive 2001/83 (a link to the directive here) outlines the qualifications and necessary experience to become a QP. The part of the Article reads: 
"A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology."

After reviewing this Directive, I came up with the following question:
1)  Is a "diploma or certificate of qualifications" received from Non-EU Member States, to say, in Republic of Korea (e.g. a registered pharmacist in Korea), acceptable/qualified?
2)  Does each Member State have different Qualification process for QP? Is there an exam to complete to become a registed/qualified QP?

I would appreciate any comments/directions.
Thank you in advance for your help.

-------------------------------------------
Dahuin Liz Lee
Seoul
Korea, Republic of
-------------------------------------------

Siegfried,

Thank you very much for visiting my post and feedback comments.  

As for ultimate responsibility, I agree.

The info on "Orange Guide" has been updated with the 2014 version.

Again thank you.

-------------------------------------------
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------






Original Message:
Sent: 04-27-2014 11:40
From: Siegfried Schmitt
Subject: QP(Qualified Person) Qualification

Dear Chang

Though you are correct that a marketing authorisation holder needs to ascertain if a QP is suitable for their needs, it is the regulatory authority, which ultimately approves or not.
In fact, the MHRA is one authority, which has not approved certain individuals, which were named on too many applications for them to be able to carry out their duties in accordance with the regulations.

As an aside: I followed your link and I noticed mention of the orange guide. There is a much more current version available: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 - the 'Orange Guide' at www.mhra.gov.uk
Though all contents can also be accessed for free on the internet. This merely is a convenient compilation

Regards
Siegfried

-------------------------------------------
Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
-------------------------------------------






Original Message:
Sent: 04-26-2014 16:34
From: Chang Lim
Subject: QP(Qualified Person) Qualification

Mr. Lee,

Pursuant to 2001/82/EC or 2001/83/EC, it should be interpreted as "it is up to a manufacture to ensure the eligibility and suitability of a QP in their marketing application."

You may want to read my post here. 

I am using an example from UK MHRA (competent authority).  

-------------------------------------------
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------






Original Message:
Sent: 04-16-2014 05:20
From: Dahuin Lee
Subject: QP(Qualified Person) Qualification

Hello all,
I am looking for some clarification on the qualifications of QP (Qualified Person)  in EU Member States.

The Article 49 of the Directive 2001/83 (a link to the directive here) outlines the qualifications and necessary experience to become a QP. The part of the Article reads: 
"A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology."

After reviewing this Directive, I came up with the following question:
1)  Is a "diploma or certificate of qualifications" received from Non-EU Member States, to say, in Republic of Korea (e.g. a registered pharmacist in Korea), acceptable/qualified?
2)  Does each Member State have different Qualification process for QP? Is there an exam to complete to become a registed/qualified QP?

I would appreciate any comments/directions.
Thank you in advance for your help.

-------------------------------------------
Dahuin Liz Lee
Seoul
Korea, Republic of
-------------------------------------------