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Learn how the 200MHz Agilent Handheld Oscilloscope can help you make floating measurements on power control circuits safely and accurately measure power, hunt for signal irregularities and analyze line current harmonics.
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SPRINGFIELD, Mass. – March 22, 2007 – Eight individuals representing Springfield College have qualified to compete at the NCGA Women's Gymnastics Championships at the University of Wisconsin-Whitewater this upcoming weekend (Mar. 23-24).
At the 2007 ECAC Women's Gymnastics Championships, hosted by Ithaca College on March 10, Springfield did not qualify as a team for the NCGA's, finishing fourth, but the team did the next best thing by qualifying a very healthy number of eight competitors to compete for individual crowns.
As a team at the ECAC's, the Pride scored 184.450 points. Finishing ahead of SC were Brockport (188.325), Ithaca (186.425), and Ursinus (186.100). Only the top three advanced as a team.
Springfield's qualifiers included freshman Audrey Lastra (New Milford, Conn.) in the all-around, sophomore Jackie Mazzola (Framingham, Mass.) in the vault, freshman Jeanna Bradle (New Milford, Conn.) and sophomore Kristin Fairburn (Salem, N.H.) in the uneven bars, freshman Alex Ploenes (Fletcher, N.C.) and senior Keriann Hart (Hanover, Mass.) in the balance beam, and senior Heather Tuden (Londonderry, N.H.) and junior Cara Chadbourne (New Salem, Mass.) in the floor exercise.
At the ECAC's in the all-around, Lastra finished 10th with a score of 36.300. Fairburn tied for 12th with a score of 36.225.
In the vault, Mazzola finished in a tie for seventh with a score of 9.475. Freshman Ericca Castagna (Topsfield, Mass.) also finished tied for seventh with the same score.
In the floor exercise, Tuden placed eighth at 9.500. Lastra and Chadbourne tied for 10th with a tally of 9.450.
Perhaps the highlight of the entire competition for Springfield came in the balance beam where Ploenes won the event with a tremendous score of 9.725. Hart finished tied for ninth with a score of 9.375.
In the uneven parallel bars, Bradle placed 10th with a score of 9.375. Lastra was 13th at 9.325.

subset: commoncrawl


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The Associated Press
BEIRUT — President Bashar Assad has exploited his greatest advantage in the Syrian civil war — his air power — to push back rebel advances and prevent the opposition from setting up a rival government in its northern stronghold.
Along the way, fighter jets and helicopters have hit civilian targets such as hospitals, bakeries and residential buildings, according to a report released Thursday by a U.S.-based human rights group. It accused the regime of committing war crimes with indiscriminate airstrikes that have killed more than 4,000 civilians since summer.
The Human Rights Watch report said Assad's air force has dropped "imprecise and inherently indiscriminate" munitions, including cluster bombs, on civilian areas.
In recent months, large parts of northern Syria near the border with Turkey have fallen to the rebels, including several neighborhoods of Aleppo, the country's largest city. With the recent influx of more advanced weapons and other foreign aid, the rebels have also made major gains in the south, seizing military bases and towns in the strategically important region between Damascus and the border with Jordan.
Two years into the uprising, however, the Assad regime's control of the skies is hampering rebels' efforts to hold on to territory they capture with any efficiency. An interim leader of the opposition has been elected, but he and others opposed to Assad have made only a few, brief forays into rebel-controlled areas.
"The air force is extremely important for Assad right now," said Joseph Holliday, a Syria analyst at the Washington-based Institute for the Study of War.
"It has allowed Assad to prevent rebels from establishing a part of Syria where people can be safe and the opposition can focus on governing the place," he said. "It very difficult to do that without a space that is free from constant harassment from the aircraft."
Although the rebels have been able to shoot down several aircraft after capturing some heavier weapons from military bases, they are largely helpless when it comes to Assad's air supremacy.
The opposition has repeatedly asked their foreign backers for weapons that can shoot down the regime's aircraft and help hasten the fall of Assad. But the United States and its European allies have been reluctant to provide opposition fighters with anti-aircraft missiles for fear they may end in the hands of radical Muslim groups that have been the most organized fighting force on the opposition side.
The rebels also want a no-fly zone established over northern Syria, but the countries opposed to Assad have taken no action on that option, either.
The top U.S. military commander in Europe, Adm. James Stavridis, said last month that some NATO nations are looking at a variety of military operations to end the deadlock and assist the opposition forces, including using aircraft to impose a no-fly zone, providing military assistance to the rebels and imposing arms embargoes.
As with U.S. and international involvement in Libya in 2011, a resolution from the U.N. Security Council and agreement among the alliance's 28 members would be needed before NATO takes a military role in Syria, Stavridis said.
Late last year, NATO deployed Patriot batteries along Turkey's border with Syria, with the alliance's leaders emphasizing that the missiles will not be used to shoot down aircraft operating in Syrian airspace.
Military experts say it is unlikely the West will revisit the no-fly zone any time soon.
"It's not easy to just go on and establish a no-fly zone, and the West has said so before," said Beirut-based military analyst, Brig. Gen. Hisham Jaber, a retired Lebanese army officer who heads the Middle East Center for Studies and Political Research in Beirut.
"They know that the Syrian army remained strong, the air force is behind Assad, and they also know that Syria has a very sophisticated air defense system," he said.
Jaber said Syria has about 400 operational aircraft, although analysts say it is difficult to come up with reliable figures on the Syrian air force and air defenses because of the extreme secrecy that blankets its military matters.
Like his late father and predecessor, Hafez, the younger Assad stacked key military posts with members of their minority Alawite sect in the past 40 years, ensuring the loyalty of the armed forces by melding the fate of the army and the regime. The air force is particularly close to the regime. Hafez Assad was an air force pilot and commander before seizing power in 1970.
However, many pilots are Sunni Muslims, and defections from the air force since the beginning of the uprising in March 2011 have been rare.
In the most dramatic escape from Syria, a fighter pilot on a training mission flew his MiG-21 warplane to neighboring Jordan in June. Only three other pilots have reportedly defected, crossing into Jordan by land last summer.
Syrian officials denounced the pilot, who is a Sunni Muslim, and military experts with knowledge of Syria suggested that the regime has grounded Sunni pilots, relying on Alawites to carry out airstrikes instead. No order has appeared in public to support their claims.
While the air force is an important tool in Assad's battle for survival, it's not his last one, said Joshua Landis, a Syria expert at the University of Oklahoma.
"It's the 3 million Alawites who believe that they will be ethnically cleansed by the opposition if the rebels overthrow Assad," Landis said. "It's because of the fear of those who could come after him that has spread around Syrian minority communities in the past year of the revolution, that many — including Sunnis — continue fighting on the regime's side."
In their campaign against the opposition, the Syrians have been using helicopters, MiG jets and trainer aircraft to hit targets daily in the north, the east, the south and in rebel strongholds on the edges of the capital of Damascus.
"The aim of the airstrikes appears to be to terrorize civilians from the air, particularly in the opposition-controlled areas where they would otherwise be fairly safe from any effects of fighting," Ole Solvang of Human Rights Watch told The Associated Press.
More than 4,300 people have been killed since summer in such attacks that amount to "serious violations of international humanitarian law," and people who commit such breaches are "responsible for war crimes," the New York-based group said in the report, the most comprehensive study of Syrian air force operations in rebel-held areas since the beginning of the conflict. The U.N. estimates that more than 70,000 people have been killed in the civil war.
The Assad regime has significantly increased its use of air power since July, when the rebels captured territory in the north after an offensive, as well as last month after they seized their first provincial capital, Raqqa. The city is bombed almost daily.
Human Rights Watch said it inspected 52 sites in northern Syria and documented what it labeled 59 unlawful attacks by the Syrian air force in rebel-held areas.


text: Best Western Premier Governor's Suites Central Region View Website Calculate Trip Deal Available Book Online Save to foursquare Get Directions Overview:Contemporary, all-suite boutique hotel; pillow-top bedding, 32" flat screen LCD television, sofa sleepers, microwaves, refrigerators, hair dryers, iron/ironing board, coffee makers, complimentary full-hot breakfast buffet, full gym privileges, IPOD alarm clocks, valet service, complimentary wired and wireless Internet, pool, upscale authenic Italian restaurant on-site. Member Green Hotels Association. GROUPS-Meeting space for up to 40, on-site catering available. Address: Best Western Premier Governor's Suites 1501 Merrill Drive Little Rock, AR 72211 Phone: 501-224-8051 Alternative Phone: 501-221-7552 Toll-Free: 800-422-8051 Website: www.bestlittlerockhotel.com E-mail: email@example.com GPS: N34.7671440 W92.3993090 Payment Methods:VisaMasterCardDiners ClubDiscover CardAmerican Express Miscellaneous Units/Rooms: 49 No Smoking Recreation Entertainment/Bar Accessible


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Dinotopia: Journey to Chandara
James Gurney
Publisher:Trophy Pr
Publication Date:2003
In the year 1860, biologist and explorer Arthur Denison and his son, Will, set out on a sea voyage of discovery and adventure. When a powerful typhoon wrecks the ship in uncharted waters, Arthur and Will are the sole survivors. Washed ashore on a strange island called Dinotopia, they are amazed to find a breathtaking world where cities are built on waterfalls, people have found new ways to fly, and humans and dinosaurs live together in harmony. With new discoveries at every turn, Arthur and Will embark upon their own separate journeys to unearth the mysteries of Dinotopia.
More About this Book | View All Listings | View Collectible Listings
Other editions: Hardcover - 2007, Hardcover - 2003, Hardcover - 2003, Softcover - 2000, Hardcover - 1999, 1999, Hardcover - 1999, Hardcover - 1999, Softcover - 1999, Hardcover - 1998
Portions of this page may be (c) 2006 Muze Inc. Some database content may also be provided by Baker & Taylor Inc. Copyright 1995-2006 Muze Inc. For personal non-commercial use only. All rights reserved. Content for books is owned by Baker & Taylor, Inc. or its licensors and is subject to copyright and all other protections provided by applicable law.
Portions of this page may be Copyright VNU Entertainment Media (UK) Ltd., 2006, Georg Lingenbrink GmbH & Co., Tite Live, S.A or Informazioni Editoriali S.p.A. All rights reserved.


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Trade Talk: Brian Duensing
by, 07-09-2013 at 06:04 PM (473 Views)
One of the players this board has discussed trading is Brian Duensing. The thought is other teams might look to him as a left handed LOOGY.
His line 5.06 ERA, 41g, 32in, 29k, 14bb (over his career left handed hitters have a .580 OPS)
Why trade him?
Brian is 30. He will be eligible for arbitration next year. He would likely be non-tendered. Caleb Thielbar appears to be the better option with Pedro Hernandez providing depth.
Why keep him?
He certainly isnt at peak value now and has never been tried exclusively as a LOOGY. Perhaps he will find similar success as Craig Breslow found after leaving the Twins.
Which teams might fit?
Boston lost Miller but they have Breslow. The Indians are rumored to be looking for a lefty. The Reds are reportedly seeking a lefty.
What is the value of a LOOGY at the trade deadline?
I found 5 trades (and a waiver claim) over the last 3 summers involving a left handed reliever as the primary target. I am not sure Duensing is a great match as all others had ERAs under 4. When looking at the ability to get left handed hitters, he might be a match.
Brain Fuentes for (PTBNL) Loek Van Mil- 25, AA, 6.37 ERA
Javier Lopez for John Bowker and Joe Martinez both 27 year old AAAA players
Will Ohmann for Rick Vandenhurk 25, AAA starter, 4.68 ERA
Craig Breslow for Matt Albers(29) and Scot Posednik(36) major leaguers
JC Romero for Carlos Rojas 28, AA, utility infielder
Jose Mijares -waived by Royals and picked up by Giants.
There were no prospects dealt in these trades. A few were already replacement AAAA players. Van Mil and Vandenhurk were 25. Vandenhurk had started 11 games for the Marlin the previous season. None of them appeared on team top 10 lists though Vandenhurk had pitched in the futures game three years earlier.
Best Terry Ryan LOOGY trade
The Twins traded JC Romero for Alexi Casilla in 2005. The return of Casilla is far better than anything in the last three years.
How will the Twins replace Duensing?
It seems that Thielbar already has replaced Duensing. Hernandez is 6 years younger and seems better suited to relief.
Bottom Line
When looking at comps, we can expect virtually nothing in return for Duensing. He certainly would not merit a sleeper prospect. Anything the Twins are able to get in return would be a bonus. An Alexi Casilla A-Ball type prospect would be an outright steal.


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A Chester county community comes together, to
help two children battling a rare disease.
Eli and Ella Vivian suffer from Metachromatic
Leukodystrophy, a disease that attacks the brain, nerves, and muscles.
Their parents held a fundraiser Saturday
night in Phoenixville, PA. They're trying to raise enough money to fly their
family out to Milan, Italy, where doctors are conducting a gene therapy study.
Only a certain number of children are accepted into the study, so Becky and
Steve Vivian hope their kids make the cut.
Family and friends got together and formed
"Eli and Ella's Prayer Warriors". They raise faith, awareness, and money for
the children's treatment.
If you want to help raise money for Eli and
Ella's Prayer Warriors, you can find information on their facebook page.
25 FOX DriveDedham, MA 02026
Phone (781) 467-2525


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One of the most difficult things a successful artist can do is continue their success. You've reached the top. Now how are you going to stay there? It's difficult because if you change too much, you've "sold out." If you don't change, "everything sounds the same."
Pearl Jam has faced this since their sophomore album, "Vs.," came out 18 years ago. Their debut, "Ten," had skyrocketed them to unbelievable heights. They were dubbed the "best band in the world" by Rolling Stone. When "Vs." was released, it became the first record to sell over a million units in one week. They were on top.
But despite the immediate success, it was criticized. Where are the soaring solos of "Ten"? Where are the anthems? Why doesn't lead singer Eddie Vedder howl and sing? Why all the screaming? Two decades later, and the band still faces the same criticisms with every release. Why can't it be more like "Ten"?
Everyone has their own opinions, and that's great. But it's refreshing to see Vedder take a truly different approach with his latest solo effort. Some may find it gimmicky, but it's risky and it's unusual. The long-haired rocker, the one who once screamed and dove off balconies released an album of ukulele songs. Instead of worrying about recycling old sounds or evolving current sounds, he jumped off the creative cliff and didn't worry about what he'd land in.
As I say in my album review, this can be mistaken as Eddie getting old. But the whimsical and effortless songwriting on "Ukuele Songs" makes him sound younger than ever. It's carefree, it's fun. Pearl Jam has been leaning toward a more relaxed way of life these past few years, but it has never let go of its heavy-handed morals—a lot of it coming from Vedder.
There is a lot to learn from "Ukulele Songs." It's OK to try something completely different. It's OK to have fun. Is it easy for someone like Vedder to do such a thing? Absolutely. But it doesn't mean we can't take smaller steps toward what we want. And I plan on taking those steps.


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Sunstar Corporation
Warehouse Manager
Required to join a small friendly team in a busy greeting card warehouse. The applicant must have management experience, be computer literate and hold a current flexi forklift licence. Previous applicants need not apply. Competitive rates of pay.
Please forward applications, marked with position applied for: Please click the APPLY button
or Helen Etheridge, Tracks Publishing Ltd,
Unit 2, 12 Blackstone Road,
Stukeley Meadows Ind. Estate, Huntingdon, Cambs PE29 6EF
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More often than I have found "stuff," I have found people who were not only willing to share stories, but the relics, memorabilia, and artifacts that they have found as well. Here are some of the highlights from the past few weeks.
Just last Saturday, I stopped at a Redding estate sale to find it was only a barn with a couple of rooms to explore, I was un-phased as this sometimes happens through no fault of the homeowner. Once I described what I was looking for, he immediately left and returned with a small stack of religious magazines from 1914. He had found them in the attic when he purchased the home. Though he didn't want to sell them he happily gifted me with a couple and wished me well in my continuing hunt.
Later on Saturday afternoon in Brookfield, I had a similar experience – a weary but friendly trio at the end of their sale listened to my quest to find old paper and a story. "I know what you'd like." One of them exclaimed, and disappeared into the house. Sure enough, 5 minutes later I am enjoying myself as they display and describe the contents of their grandfather's trunk. It contained numerous stock certificates from the 1930s as well as other pieces of ephemera. They were gracious and invited me back if I ever wanted to do a story on their collection.
About a week ago, I was finishing up at meeting of the Flagpole Radio Café (Season 5 announcement — coming soon) when, as I was leaving, one of the producers came up to me and said, "Here, I saw this and I thought you might find it interesting." He was holding a nicely preserved WWII Ration book. After thanking him, I had to think a minute about my good fortune to not only be able to find the things that I do, but to have friends around me that want to help. It's a good feeling.
I have already written about the benevolent neighbor who , but there are others who I don't want to miss. Most importantly, the kind reception I have gotten from the Newtown Friends of the Library publicist, Toni Earnshaw. She invited me to visit while volunteers inspected and sorted books back on "Donation Day." While I didn't find any treasure between the pages of those books, just a week ago Toni stopped by my office to hand me a treasure they had recently found — an order form for a series of Washington Irving's stories from 1896.
If you like to hunt for treasure I recommend stopping by Reed Intermediate school in Newtown, July 14-18 to see what is likely the largest book sale in the state. This is an important fundraiser for them and from the volume and quality of this year's donations there will be some real standouts to look for. My favorite is the "Special Collections" room they have dedicated to rare, old, and signed books. Don't miss it.
Finally, I would like to thank all the folks who commented and emailed me on last week's story of the . I was given several good leads that I am currently following up: Tarrywile Mansion, Danbury; Nyala Farms in Westport, CT; Muscoot Farm in Katonah, NY…all good guesses, but nothing firm to back them up. Take another look and see if it rings a bell. Even if it doesn't, I am appreciative for all the help and interest in Urban Archeology.
Greg Van Antwerp is a Brookfield resident and blogger, who can be found on the weekends in search of a good "dig" or a good story. You can read more about his adventures by visiting his blog.


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- Home
- Human regulatory
- Pre-authorisation
- Q&A: Presubmission guidance
- Questions 21-30
This page lists questions 21 to 30 of the European Medicines Agency's questions and answers on presubmission guidance.
The page is updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation. Revised topics are marked 'New' or 'Rev.' on publication.
Jump to other questions
- 21. Am I, as applicant, duly established in the European Economic Area? Rev. February 2012
The marketing-authorisation holder (MAH) is the person who holds the authorisation to place a medicinal product on the market and is legally responsible for marketing the medicinal product. The granting of a marketing authorisation by a competent authority does not discharge the holder from civil and criminal liability as provided for by European Union law.
The MAH may be a natural or legal person.
The MAH of a centralised marketing authorisation must be established within the European Economic Area (EEA; Norway, Iceland, Liechtenstein and the Member States of the European Union).
In order to fulfil this requirement, the MAH must have a permanent legal structure that is formed in accordance with the law of an EEA Member State and allows the concerned holder to assume the duties and responsibilities as well as to perform the tasks laid down by Union law.
Companies or firms formed in accordance with the law of a Member State and having their registered office, central administration or principal place of business within the EEA will be treated in the same way as natural persons who are nationals of Member States. An applicant should demonstrate that it is duly established in the EEA. A proof of establishment from the applicant company is required by the Agency in order for an application to be validated (e.g. in the United Kingdom, a certificate of incorporation issued by the Registrar of Companies, and in France, an extrait du registre du commerce et des sociétés). This proof of establishment should be included in annex 5.3 of the application form.
It should be emphasised that while the MAH may delegate certain activities to third parties, the MAH remains responsible for assuring all the obligations imposed on MAHs by the European legislation and by national law, as applicable.
- 22. What information relating to the manufacture and batch release should be provided as part of my application? Rev. February 2012
The Agency requires the applicant to provide background information in support of the application relating to the manufacture (including packaging), batch testing and batch certification (batch release) by the qualified person in the EEA. This should be sent to the Agency along with the application dossier.
The EEA includes European Union (EU) Member States plus Iceland, Norway and Liechtenstein. Switzerland is not part of the EEA.
Once validated, it is normally not permitted to add a new site or to change the steps of manufacture or batch release described under module 1.2 (i.e. the application form) of the application during the 210-day review period. Any additional sites or changes in the manufacturing or batch-release arrangements should be submitted as a variation after the granting of the marketing authorisation.
The information on manufacturing and batch-release sites submitted in module 1.2 of the application must be consistent with module 3. All the manufacturing and batch-release sites mentioned in module 3 must be listed in module 1.2 and the activities carried out at each site must be described in module 1.2 consistently with the information provided in module 3.
Manufacturing sites
All sites involved in the production of the finished medicinal product and of the active substance must be described (name and detailed address, including building reference) in module 1.2 of the application for a marketing authorisation, together with a description of the steps performed. This should include:
- active-substance manufacture and packaging;
- any contract laboratories used for testing the active substance (including ongoing stability monitoring);
- bulk medicinal-product manufacture;
- diluent / solvent manufacture (if any);
- manufacture of any other associated medicinal products (if any);
- finished-product manufacture and packaging;
- batch release;
- any contract manufacturing sites;
- any contract laboratories used for testing the finished product;
- official medicines control laboratory (OMCL) for blood products and vaccines if official batch release is a requirement for the product in question.
For third-country manufacturers, information about any previous EEA inspections in the last two to three years and any planned EEA inspections should be provided. This should include details of the inspection dates, product categories inspected and the name of the inspecting competent authority.
Documents to be attached to module 1.2 of the application
The following documents should be attached to module 1.2 of the application:
- copies of the manufacturing authorisation authorising the sites involved in the manufacture, importation, control and testing and qualified-person release of batches of the medicinal product for all sites in the EEA, other than active-substance manufacturers. Alternatively, a reference can be made to the appropriate entry in the EudraGMDP database.
For sites in the EEA, good-manufacturing-practice (GMP) certificates are not an acceptable alternative to a manufacturing authorisation. However, GMP certificates can be useful additional information. Also, particular attention should be paid that the scope of the manufacturing authorisation for a given manufacturer covers the activities proposed as part of the marketing-authorisation application;
- a mutual-recognition-agreement (MRA) certificate for all sites other than active-substance manufacturers located in third countries where an MRA or other relevant agreement is in place. This certificate must not be older than three years, and must come from the local competent authority that carried out the inspection. Alternatively, a GMP certificate from the EEA inspecting competent authority should be provided if the site has been inspected by an EEA competent authority in the last two or three years. Where the MRA partner has placed the certificate in EudraGMDP, a reference to the entry will suffice. For a list of the countries that have operational MRAs with the EU, please consult MRAs;
- for all sites other than active-substance manufacturers located in third countries with no MRA, a GMP certificate from the EEA inspecting competent authority if the site has been inspected by an EEA competent authority in the last two or three years. Alternatively, a reference can be made to the appropriate entry in the EudraGMDP database;
- in addition to the above, a copy of the registration or other document analogous to a manufacturing authorisation from the local competent authority demonstrating that the site is authorised for manufacture of the product or pharmaceutical form and details of any inspections performed other than by EEA authorities (e.g. GMP certificates or similar statements from the competent authority that carried out the inspection);
- a flowchart describing all the main steps involved in the manufacture of the active substance and finished product;
- for each active substance, a declaration from the qualified persons for all of the finished product manufacturers located in the EEA listed in module 1.2 where the active substance is used as a starting material and from the qualified persons for the batch release sites in the EEA, sttaing that the active substance manufacturers listed in module 1.2 operate in compliance with the detailed guidelines on GMP.
Contact person in the EEA for product defects and recalls
A proposed contact point or person in the EEA for quality problems and defective batches of product must also be provided in module 1.2 of the application (name, full address, 24-hour emergency telephone and fax numbers, e-mail address, and mobile telephone number, if available).
- 23. What batch-release arrangements in the EEA are required for my medicinal product? Rev. February 2012
Importing site and supervisory authority
According to Article 51(1) of Directive 2001/83/EC, each batch of a medicinal product must be certified by a qualified person prior to release onto the market in the EEA.
In the case of products imported from a third country, and for the purpose of Article 51(1)(b) of Directive 2001/83/EC, the site where the certification of batches by the qualified person occurs is considered to be the importing site in the EEA, and not necessarily the site through which the batch first physically enters the EEA.
The EEA includes EU Member States plus Iceland, Norway and Liechtenstein. Switzerland is not part of the EEA.
In accordance with the provisions of Article 18 of Regulation (EC) No 726/2004, the supervisory authority is the competent authority of the Member State that granted the manufacturing authorisation provided for in Article 40(1) of Directive 2001/83/EC in respect of the manufacture of the medicinal product. In the case of products imported from third countries, the supervisory authority is the competent authority of the Member State that granted the manufacturing authorisation provided in Article 40(3) of Directive 2001/83/EC to the importer, unless an MRA or other relevant agreement covering GMP for the product under consideration is operating with the country where the medicinal product is manufactured.
In the exceptional cases where a valid manufacturing authorisation is not in place at the time of the marketing-authorisation submission for any finished-product manufacturer, importer or batch-release site located in the EEA, the Agency will consult the supervisory authority and a request for inspection may be triggered. The marketing-authorisation procedure will require the inspection outcome before opinion and, in particular, confirmation of the granting of the manufacturing authorisation.
For any finished-product manufacturer that is not in possession of a GMP certificate at the time of the marketing-authorisation submission located in third countries with no MRA, a request for inspection will normally be triggered. The marketing-authorisation procedure will require the inspection outcome before opinion.
Batch testing upon importation
For medicinal products imported from third countries, retesting of each batch within the EEA upon importation is required unless an MRA or other relevant agreement covering GMP for the product under consideration is operating with the country where the medicinal product is manufactured. If such an MRA is in operation, batch controls and tests carried out in the country where the product is manufactured are acceptable.
It should be noted that MRAs cover batch control and testing and do not cover batch release. Batch release must take place in the EEA territory for every production batch released to market in the EEA, regardless of whether an MRA with the exporting country is in place or not.
For the countries that have operational MRAs with the EU, see MRAs.
Batch release of an imported medicinal product from a third country without retesting is a serious failure of a qualified person's legal obligations. According to Article 52 of Directive 2001/83/EC, it is expected that Member States' supervisory authorities will launch appropriate administrative measures and may withdraw the product concerned from the market (Article 117(1)(e) of Directive 2001/83/EC).
Contracting out of certain controls
The provisions of Article 20(b) of Directive 2001/83/EC allows some of the controls required under the provisions of Article 51(1) of Directive 2001/83/EC to be contracted out to third parties, if justified, and provided that the laboratories have been verified by the competent authorities. Laboratories used for contract testing upon importation of medicinal products manufactured in third countries may be located in any EEA country.
The qualified person of the manufacturing-authorisation holder named in the application is however responsible for certifying that any contract laboratory used carries out the controls in accordance with GMP, as applicable and with the requirements of the marketing authorisation, once granted.
- 24. How should I submit an active-substance master file (ASMF)? Rev. December 2013
Annex I to Directive 2001/83/EC describes the concept of an open and closed Active Substance Master File (ASMF) and specifies that:
"For a well-defined active substance, the active substance manufacturer or the applicant may arrange for the:
i) Detailed description of the manufacturing process
ii) Quality control during the manufacture, and
iii) Process validation
to be supplied in a separate document directly to the competent authorities by the manufacturer of the active substance as an Active Substance Master File.
In this case, the manufacturer shall, however, provide the applicant with all of the data, which may be necessary for the latter to take the responsibility for the medicinal product…"
It should be emphasized that the concept of the ASMF shall only apply to a well-defined active substance and cannot be used for excipients, finished products and biological active substances. The information related to excipients, finished products and biological active substances shall be provided within the Marketing Authorisation Application (MAA) by the applicant.
In case an application under the Centralised Procedure includes the submission of an Active Substance Master File (previously referred to as European Drug Master File (EDMF)), applicants should be aware of the fact that, as mentioned in the Guideline on Active Substance Master File Procedure (CPMP/QWP/227/02), an ASMF consists of 2 parts:
- An ASMF Applicant's Part, also referred to as Open Part, which shall be at the disposal of the applicant.
- An ASMF Restricted Part, also referred to as Closed Part, which is a confidential document closed to the applicant.
Both parts need to be separated and follow the structure of the Module 3.2.S of the CTD.
The content requirements as described in the above mentioned Guideline should be followed.
It is necessary for the applicant and the ASMF holder to liaise to ensure that the ASMF including all necessary documents are synchronized to arrive at ideally the same time as the planned MAA to be submitted by the applicant, although an interval of some days may be allowed.Note that the marketing authorisation application cannot be validated until all the necessary documents are received in a satisfactory form. This also applies to the ASMF-related responses to Day 120 LoQ and Day 180 LoOI. Applicants should be aware that the procedure cannot re-start until the responses from the ASMF holder are received by the Agency.
Non applicability of ASMF concept to biological active substances
Further to clarifications from the European Commission on the interpretation of Directive 2001/83/EC as amended, and the subsequent announcement in the October 2004 CHMP Monthly report, the ASMF concept is not acceptable for biological medicinal products.
The characterisation and determination of biological active substances requires not only a combination of physico-chemical and biological testing, but also extensive knowledge of the production process and its control.
The MAH/applicant for a biological medicinal product could therefore not comply with the requirement to 'take responsibility for the medicinal product' without having full and transparent access to these quality-related data. The use of an ASMF would prevent such access, and should therefore not be allowed for biological active substances.
In addition, active substances, which are present in certain medicinal products such as vaccines or cell therapy medicinal products, do not fit with the concept of a 'well-defined' active substance.
Non applicability of ASMF concept of open and closed parts to Vaccine Antigen Master File (VAMF) and Plasma Master File (PMF)
The concept of the ASMF does not apply to blood derived medicinal products and vaccine antigens. In this context, the manufacturer can submit a PMF or a VAMF.
Regarding the VAMF, the legislation specifies that the VAMF holder cannot differ from the MAH/applicant for the concerned medicinal product: there is hence no rationale for an open /closed parts system.
For VAMF linked MAs, if a particular MAH name and address are not identical to the name and address of the proposed VAMF certificate holder, a relevant declaration should be provided attached to the application form, stating that the MA applicant and the MAH belong to the same mother group of companies, which share the same data package.
For the PMF the legislation specifies that where the MAH/applicant differs from the holder of the PMF, the PMF shall be made available to the MAH/applicant for submission to the competent authority.
- Annex I to the Directive 2001/83/EC, as amended
- Guideline on Active Substance Master File Procedure
- Procedural announcement CHMP Monthly report October 2004
- CMD(h) – Overview of Biological Active Substances of non-recombinant origin
- Guideline on requirements for Vaccine Antigen Master File (VAMF) certification
- Guideline on requirements for Plasma Master File (PMF) certification
What data should be submitted by the ASMF holder? Rev. Dec 2013
In the first submission of an ASMF with an allocated EMEA ASMF reference number, the ASMF holder is required to submit:
- ASMF dossier (Applicant's part, Restricted part, Quality Overall Summary and Expert's curriculum vitae);
- Letter of Access (Annex 2 of the ASMF Guideline);
- Submission Letter and Administrative Details (Annex 3 of the ASMF Guideline);
- A commitment to inform the applicant and the EMA of any change in the ASMF to be provided either as a separate letter or within the Letter of Access (Annex 2 of the ASMF Guideline).
In later marketing authorisation application or variations submissions referencing to an already submitted ASMF with an allocated EMEA/ASMF number, the ASMF holder is only required to submit:
- Letter of Access (Annex 2 of the ASMF Guideline);
- Submission Letter and Administrative Details (Annex 3 of the ASMF Guideline);
- The relevant revised sections of the ASMF dossier reflecting changes to the previously accepted version, as applicable;
- A commitment to inform the applicant and the EMA of any change in the ASMF to be provided either as a separate letter or within the Letter of Access (Annex 2 of the ASMF Guideline).
The Letter of Access and the Letter of Commitment to inform the applicant about any changes in the ASMF should be included both in the application form submitted by the applicant (Annexes 5.10 and 5.11) and also in the ASMF submitted by the ASMF holder.
The contact details of the ASMF holder contact person (including contact email address) must be the same in the Cover Letter of the ASMF, in the Letter of Access and the Application Form (Module 1.2 of the eCTD or NeeS submission).
ASMF holders are reminded that any initial submission and update to an ASMF should be accompanied by the Submission Letter and Administrative Details (Annex 3 of the ASMF Guideline) dully filled as detailed in the instructions provided in the Additional guidance on documents relating to an active substance master file. Either an EMEA/ASMF/xxxxx number or EU/ASMF/xxxxx number has to be entered.
New MAA or MAV should always reference the last version of the ASMF submitted. This will be subject to compliance checks during validation of the MAA and MAV.
The ASMF dossier and any subsequent updates should only be submitted once.
What data should be submitted by the applicant or MAH? Rev. Dec 2013
In all cases, the applicant (in the context of a MAA) or MAH (in the context of a MAV) should submit:
- MAA and MAV application form stating the correct EMEA ASMF reference number;
- Copy of the Letter of Access (Annex 2 of the ASMF Guideline[TB1] ), as applicable;
- Copy of the complete current version of the Applicant's part of the ASMF in Module 3 or its revised sections, as applicable;
- Copy of the commitment from the ASMF holder to inform the applicant and the EMA of any change in the ASMF to be provided either as a separate letter or within the Letter of Access (Annex 2 of the ASMF Guideline).
The Letter of Access and the Letter of Commitment to inform the applicant about any changes in the ASMF should be included both in the application form submitted by the applicant (Annexes 5.10 and 5.11) and also in the ASMF submitted by the ASMF holder.
The latest version of the ASMF submitted in the context of a previous centralised procedure will be considered the current version of that ASMF. The current version of the ASMF should correspond to the version of the ASMF Applicant's part declared in a new MAA or MAV form and included in Module 3. This will be subject to compliance checks during validation of the MAA and MAV.
The version of EMEA/ASMF/12345 (EMA/ASMF/reference number) currently held at the Agency is: AP January 2012/RP April 2013.
If the version of the ASMF included in the Module 3 of the MAA and referenced in the application form is AP November 2011, the applicant will be requested to update Module 3 and the application form according to the current version of the EMEA/ASMF/12345.
Equally, if the version of the ASMF included in the Module 3 of the MAA and referenced in the application form is AP December 2012, the ASMF holder will be requested to submit the latest version of the ASMF together with the Annex 3 of the ASMF Guideline.
ASMF Holders are reminded of their responsibility to inform the MAHs of any changes to their ASMFs. Similarly, MAHs are reminded of their legal obligation to submit the applicable variation to their MAs when changes are proposed to the ASMF, i.e. when an updated version of the ASMF is submitted, the MA(s) linked to that ASMF will only integrate the ASMF update once the applicable variation is submitted and positively concluded.
The applicant should submit the Applicant's Part of the ASMF. It should be included in their application within Module 3.2.S of the dossier. The ASMF holder should only submit updates to the Applicant's Part (which should be identical to the one provided by the applicant) and/or Restricted Part, as applicable, in the context of a MAA or MAV. Both parts should be the latest versions available of the ASMF. It is recommended to include a table summarising those changes made to the ASMF compared to the previous version.
Applicants should note that the ASMF constitutes an integral part of the dossier and therefore it should be always made available to the EMA and CHMP Members.
The applicant is responsible for the submission of all necessary documents to the EMA.
It should be noted that although the ASMF procedure is developed to keep intellectual property confidential, it is also permitted to use the procedure when the applicant is also the manufacturer of the active substance.
Additional information on the ASMF procedure can be found in the ASMF WG webpage.
What is the EMEA/ASMF reference number? Rev. Dec 2013
From 1 September 2013, ASMF holders submitting their ASMF dossiers relating to a Centrally Authorised Product are asked to send it to the Agency and Committee Members only once.
According to the new ASMF submission rules the Agency will assign a reference number on request prior to submission of the ASMF that can cover multiple CAPs.
The EMEA/ASMF/XXXXX number is an internal reference number sequentially assigned by the EMA to enable an appropriate data lifecycle management of ASMFs used in one or more centralised Marketing Authorisation.
The EMEA ASMF reference number does not replace the responsibility of the ASMF holders to version control their ASMF (in accordance with GMP) nor replaces their own ASMF numbering system.
Who should request an EMEA ASMF reference number? Rev. Dec 2013
The EMEA ASMF reference number should be requested by the ASMF holder for:
- new ASMFs submitted for MAAs and MAVs as of 1 September 2013. From this date, reference to an EMEA ASMF number will be checked at validation,
- ASMFs previously submitted to the EMA when referenced in a new MAA or MAV. The request for the EMEA ASMF reference number should be made before submission of a new MAA or MAV to update the ASMF.
- ASMFs submitted in relation to a variation application.
For previously submitted ASMFs, in cases where the ASMF is used in more than one MA the ASMF Holder should only request one EMEA ASMF reference number, when applicable1. The allocated EMEA ASMF reference number should be communicated to the applicant or MAH, so that reference to the EMEA/ASMF/XXXXX number is made in all future submissions.
When and how to request an EMEA ASMF reference number?
Up to two weeks before submitting a complete ASMF, or an update to an already submitted ASMF, the ASMF holder should request the EMEA ASMF reference number. The request should be sent to firstname.lastname@example.com.
Agency ASMF reference numbers are allocated sequentially. A request form is available.
The EMEA ASMF reference number allocated by the Agency should be referenced in all subsequent communications (e.g. in response to a validation issue, List of Questions, List of Outstanding Issues, upcoming variation) and should always be included in the following documents:
- MAA (in the field of the National ASMF number) or MAV application form (in the Present and Proposed field);
- Letter of Access (Annex 2 of the ASMF Guideline);
- Submission Letter and Administrative Details (Annex 3 of the ASMF Guideline).
It is the responsibility of the ASMF holder to inform the applicant of a MAA or MAV of the allocated EMEA ASMF reference number. Failure to state a valid EMEA ASMF reference number on the MAA or MAV form will trigger validation questions and may delay the start of procedure.
EMEA ASMF or EU ASMF reference number? Rev. Dec 2013
The EU/ASMF reference number allows for the identification by all Competent Authorities(National Competent Authorities and EMA) of ASMFs used in centralised and national (Decentralised and Mutual Recognition) MAAs or MAVs, and therefore enabling the ASMF Assessment Report Work Sharing (ASMF AR WS) procedure.
More information on the ASMF AR WS will be made available closer to the start of the pilot phase (1 December 2013) in the dedicated ASMF WG webpage.
ASMF holders should either have an EMEA/ASMF/ reference number or an EU/ASMF/ reference number before submitting an ASMF. Both numbering systems will run in parallel as of the start of the pilot phase of the ASMF AR WS. ASMF holders are encouraged to request an EU/ASMF/reference number if the ASMF is expected to be used in centralised and national applications.
Which format and submission channel should be used for submitting ASMFs?
Under the new ASMF submission requirements, the following formats are accepted for ASMF submissions:
- Electronic Common Technical Document (eCTD);
- Non-eCTD electronic submission (NeeS).
Guidance on the above formats can be found on the eSubmission website. Additional, please take[TB3] a note of the EMAs statement of intent of the mandatory use of eSubmission Gateway.
Submission to the EMA
ASMF Holders should send applications as CD-ROM or DVD for the attention of the Product and Application Business Support (PA-BUS):
Product and Application Business Support (PA-BUS)
European Medicines Agency
Loading Dock
Ontario Way
Canary Wharf
London E14 4HB
Only one CD-ROM or DVD of the ASMF submission should be submitted to the Agency, together with one original, signed cover letter.
Submission requirements for the different Committee (Co-) Rapporteurs
ASMF holders must submit the application to all (Co-)Rapporteurs, otherwise there may be a delay in the start of the procedure due to the time lapse between the validation by the Agency and the confirmation from the (Co-)Rapporteurs that they have received the dossier. In case of a CD-ROM or DVD submission to the EMA, the submission to the (Co-)Rapporteurs should be sent at the same time as the submission is sent to the Agency.
For a full overview of the submission requirements for the different Committee (Co‑)Rapporteurs see:Dossier requirements for Centrally Authorised Products (CAPs).
The above method and requirements also apply to the submission of responses to List of Questions / List of Outstanding Issues.
How to proceed if the ASMF was previously submitted in paper format? Rev. Dec 2013
The ASMF holder of ASMFs previously submitted in paper format should request an EMEA ASMF reference number as indicated above.
After the reference number is allocated the ASMF holder should submit the ASMF in an accepted electronic format (Electronic Common Technical Document (eCTD) or Non-eCTD electronic submission (NeeS).
How to proceed if there is an existing eCTD life-cycle for the ASMF ? NEW Dec 2013
ASMF holders need to request the EMEA/ASMF number by filling the request form. The EMA will provide the requestor with the new number within 3working days. Please note that this number is NOT equivalent of EU/ASMF number and should never be inter-changed.
If the ASMF holder already has more than one eCTD life-cycle filed for the given substance, they will need to select one of these (informing the EMA in the cover letter which one it will be) and follow the eCTD life-cycle of the selected 'product' only. This, selected life-cycle will, then receive a new EMEA/ASMF/01xxx number covering all listed CAPs.
Once the ASMF holder is submitting an update or new version to the ASMF, they have to do so with thisnew number. The ASMF holder will have to prepare a new sequence (increasing by one) in which (module 1, cover letter) they declare that the previously submitted ASMF version has not been modified since it was last submitted.
If there have been modifications (new version) since the last ASMF submission, additonally the relevantmodules within this new eCTD sequence will have to be updated.
ASMF holders have to inform all MAH(s) about the new EMEA/ASMF/xxxxx number and if an update is submitted to an ASMF related to their Centrally Authorised Product (the MAH should then submit the relevant variation application)
1Example: substantially different route of synthesis/manufacturing process which results in changes to important quality characteristics of the active substance, e.g. bioavailability of the active substance, may result in the allocation of two different EMEA/ASMF numbers.
- 25. What should I submit if my medicinal product contains or consists of genetically modified organisms (GMOs)?
Potential applicants are advised to discuss their future applications that consist of or contain GMOs well in advance (six months to a year) of their submission to the Agency.
Applicants may also find it useful to apply for scientific advice during the development of their medicinal product. For any scientific-advice questions relating to environmental risk assessment (ERA), the necessary consultations will be held with the designated GMO competent authorities.
With the letter of intent to submit an application for a marketing authorisation under the centralised procedure for a medicinal product containing or consisting of GMOs within the meaning of Article 2 of Directive 2001/18/EC, the applicant will be required to provide a confirmation that all obligations have been complied with. It is necessary to ensure the traceability at all stages of the placing onto the market of GMOs as or in products authorised under part C (Article 12) of the abovementioned Directive.
Article 6 of Regulation (EEC) No 2309/93 specifies the documents to be presented in module 1.6.2 for an MAA for a medicinal product consisting of or containing GMOs:
- a copy of the competent authority's written consent to the deliberate release into the environment of the GMOs for research and development purposes. Although already appearing in module 1 (annex to the application form), this information should be repeated in module 1.6.2;
- the technical and scientific information on the GMO specified in annexes III and IV to Directive 2001/18/EC. As the Directive qualifies this point with a statement to the effect that not all listed points may be applicable to particular GMOs or GMO categories, the list in these annexes should be understood to be a compilation of points to consider, which is subject to justified deletions or additions, depending on the nature of the medicinal product. The information also needs to take into account, inter alia, the diversity of sites of use of the GMO and the results of research and trials already completed on the GMO;
- the ERA dossier. The content of this dossier should follow the order of headings and requirements specified within annex II to Directive 2001/18/EC and expanded upon in Commission Decision 2002/623/EC;
- the results of any investigations performed for the purposes of research or development.
In addition and in analogy with the requirements of Article 6 of Regulation (EEC) 2309/93, it is recommended to complete module 1.6.2 with the following:
- information on the proposed product information (including proposed conditions of use and handling) and on the packaging of the product. Although already appearing elsewhere in the MAA, this information should be repeated in module 1.6.2 for the benefit of the lead consulted competent authority, which will not receive the full MAA dossier;
- a plan for monitoring, in accordance with Council Decision 2002/811/EC, during the period of use and beyond, of the product, or a justification for the omission of such a plan;
- a summary following the summary information format set out in the Annex to Council Decision 2002/812/EC;
- bibliographical references.
The module section 1.6.2, presenting all these particulars, should be bound separately from the remainder of the dossier. Moreover, there is no provision for a summary to be included in module 2 of the dossier.
The fundamental dossier requirements for ERAs for GMOs proposed to be placed on the market as or in products are included in Directive 2001/18/EC and in Commission Decision 2002/623/EC.
Technical and scientific information presented in the ERA will overlap with items of information presented in other sections of module 1, and other modules of the MAA dossier. Applicants are reminded to ensure full consistency of all data throughout the dossier, bearing in mind that variability, reflecting different origins (medicinal product regulatory versus environmental regulatory texts) may occasionally be encountered in the official terminology describing GMO attributes.
This Directive 2001/18/EC shall not apply to GMOs as or in products as far as they are authorised by Council Regulation (EEC) No 2309/93 provided a specific environmental risk assessment is carried out in accordance with the principles set out in Annex II to this Directive and on the basis of the type of information specified in Annex III to this Directive.
Council Regulation (EEC) 2309/93, as amended, requires that the rapporteur hold necessary consultations with the competent national authorities under Directive 2001/18/EC, where the medicinal product contains or consists of GMOs.
To accelerate the consultation process, the CHMP rapporteur may appoint one of the national GMO competent authorities to act as lead consulted competent authority. This lead consulted competent authority will liaise with its fellow GMO competent authorities on the review of the documentation forwarded to it by the applicant.
The assessment report on the module 1.6.2 data, prepared by the lead consulted competent authority and including any comments received from the fellow competent authorities, will be sent to the rapporteur for CHMP consideration. The CHMP members will subsequently have the opportunity to comment on all aspects of the scientific assessment. The environmental assessment is an integral part of the assessment report, and is done accordingly to the same timelines.
It should be highlighted that current experience under the centralised procedure with medicinal products containing or consisting of GMOs is rather limited. Once more experience is accumulated, a standard operating procedure will be prepared by the Agency for discussion and adoption by the CHMP.
- Council Regulation (EEC) No 2309/93
- Council Directive 2001/18/EC
- Commission Decision 2002/623/EC
- The rules governing medicinal products in the European Community, notice to applicants, volume 2B, presentation and content of the dossier
- Guideline on ERAs for medicinal products containing, or consisting of, GMOs
- 26. What information should I provide if my medicinal product contains or uses materials of animal or human origin in the manufacturing process? Rev. July 2006
The applicant must comply with the part I module 3.2 (9) 'content: basis and principle' of annex I to Directive 2001/83/EC, as amended, which requires that:
The applicant must demonstrate that the medicinal product is manufactured in accordance with the note for guidance on minimising the risk of transmitting-animal-spongiform-encephalopathy agents via medicinal products...
and its updates.
Demonstration of compliance with the note for guidance on minimising the risk of transmitting-animal-spongiform-encephalopathy agents via medicinal products can be done by submitting certificates of suitability from the European Directorate for the Quality of Medicines and Healthcare (EDQM) (in annex 6.12 of the application form) or by inclusion of the dossier of scientific data in module 3.2 to substantiate this compliance. In the latter situation, this data should be reviewed in module 2.3 (expert reports).
For all applications, table A on materials of animal origin covered by the notice for guidance on minimising the risk of transmitting-animal-spongiform-encephalopathy agents via medicinal products should be completed and included in module 3.2.R.
For materials from animals not covered by the notice for guidance on minimising the risk of transmitting-animal-spongiform-encephalopathy agents via medicinal products and annex I to Directive 2001/83/EC as amended, applicants are requested to complete the table B on 'other materials of animal origin', and include it in module 3.2.R.
Materials of human origin
If an application relates to a medicinal product that contains or uses materials of human origin in its manufacture, applicants are requested to complete the table C on albumin and other human-tissue-derived materials and include it in module 3.2.R.
- 27. Where in my medicinal product information can I mention a local representative? Rev. January 2006
Some holders of Community marketing authorisations have requested that there be a contact point identified in the package leaflet and on the label. This would normally be the holder of the Community marketing authorisation. However, an MAH may wish to add the name of another (local) contact point, the 'local representative'.
'Local representatives' shall be taken to mean any private or legal person established in the Community charged, through a civil contract with the MAH, with representing it in a defined (geographical) area, this contract excluding any transfer of any responsibility imposed on the MAH by Community law and by national law, regulation and administrative action implementing such Community law.
The local representative may be indicated:
- in the package leaflet, under heading 6 as detailed in the product-information templates, by name, telephone number and e-mail address (optional) only. Postal address may be added space permitting;
- by name in the blue box on the label, as long as not it does not interfere with the legibility of the EU text on the outer packaging, and if mentioned, in the leaflet.
All telephone numbers should be accessible when dialled from abroad (e.g. when a toll-free number is given that is not accessible from abroad, an alternative international number has to be added).
Reference to website addresses or to e-mails linking to websites are not allowed, either for the marketing authorisation holder or for the local representative.
Designation of a local representative cannot be a requirement but, when the holder of a Community marketing authorisation wishes to identify a local representative in the leaflet, the whole Community must be covered so that the consumer in each Member State and EEA country has equivalent access to a local representative. A local representative may be designated for more than one Member State or EEA country and may also be the MAH when no other local representatives are indicated. Moreover, in principle, only one local representative should be indicated per Member State or EEA country. Local representatives should be able to address queries in the local official EEA language of the country for which he or she is designated.
There has been some confusion with regard to terms such as 'exploitant', 'technical director' and 'distributor'. Since there is neither a commonly agreed understanding of these terms nor an equivalent legal definition of them amongst the Member States, and in the absence of any reference or definition in Community law, reference to such terminology will not be accepted for a medicinal product authorised by the Community.
It must be recalled that Member States may not require that a local representative of the MAH be appointed for their territory. Therefore, the arrangements outlined above are purely optional for holders of Community marketing authorisations.
- 28. How and to whom should I submit my dossier? Rev. December 2013
In order to fulfil EU dossier requirements applicants must submit new Marketing Authorisation Applications (MAA) as follows:
Languages to be used
All applications have to be submitted in English.
Format of submission
From 1 January 2010, eCTD is the only acceptable electronic format for all applications and all submission types in the context of the centralised procedure (e.g. new applications, variations, renewals). Any other electronic format, including NeeS, will be automatically rejected and the submission receipt will not be acknowledged. Additionally, if the eCTD submission results in an invalid Technical Validation the submission will not be accepted.
The latest version of the ICH M2 eCTD specification can be found at http://www.ich.org/products/electronic-standards.html, and the current version of the eCTD EU Module 1 specification can be found in the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2B or the eSubmission website with related documents.
Where applications are amended during the agency's review, such as e.g. responses to the lists of questions or a withdrawal, a new or consolidated eCTD sequence should be provided in order to maintain the eCTD life-cycle. Replacement sequences of a previously submitted eCTD application (e.g. following corrections) are not acceptable. Any modification of an eCTD application must be reflected in a new eCTD sequence.
For further information regarding the e-submission requirements in the context of the Centralised Procedure, please refer to the TIGes Harmonised Guidance for eCTD submissions.
Cover letter
The European Medicines Agency is standardising the administrative information required in cover letters for any submission concerning centralised procedures. This is in line with changes to the internal financial system and quality improvements to distribution workflows. The Summary Table should be incorporated in the cover letter of each submission in the Centralised Procedure (see explanatory notes in the template).
Please refrain from sending additional and separate copies of cover letters and CD/DVDs, as they will create delays in processing.
Product Information (PI)
As per eCTD requirement, the Product Information (SmPC, PIL and labelling) has to be submitted within the module 1 of the eCTD structure in PDF format. Additionally, this information should also be submitted in Word format outside the eCTD structure but in the same eSubmission Gateway and eSubmission Web Client package or CD-ROM or DVD within a folder called "xxxx_working documents", where the number (xxxx) equals the sequence number
Active Substance Master File (ASMF)
In cases where an Active Substance Master file (ASMF) exists, the applicant should ensure that the Active Substance Master File is or has been submitted by the ASMF holder to the Agency (see also question "Submission of a ASMF"), in order to proceed with the validation of the dossier.
Submission to the EMA
The EMA strongly recommends using the eSubmission Gateway or the eSubmission Web Client as the preferred submission methods of all eCTD submissions. More information on how to register and connect to the Gateway / Web Client can be found in the eSubmission website and detailed information on the required naming conventions and file formats can be found in the Gateway Q&A and the Web Client Q&A. Applicants must not send duplicate submissions electronically or via CD-ROM or DVD as this might lead to delays in the handling of applications.
Applications that are sent using the eSubmission Gateway and eSubmission Web Client will receive an automated 'acknowledgement', confirming whether their submission has passed the applicable technical validation criteria and has been uploaded to the agency's review tool. There is no need to send any separate paper cover letters for these submissions, as the cover letter will be in the relevant part of eCTD module 1 in PDF format.
MAHs not yet using the eSubmission Gateway or the Web Client solution should send applications as CD-ROM or DVD for the attention of the Product and Application Business Support (PA-BUS):
Product and Application Business Support (PA-BUS)
European Medicines Agency
Loading Dock
Ontario Way
Canary Wharf
London E14 4HB
Only one CD-ROM or DVD of the Marketing Authorisation Application (MAA), including the applicant's part of the active Substance Master File, where applicable should be submitted to the Agency, together with one original, signed cover letter when using this format of submission.
Submission requirements for the different Committee (Co-)Rapporteurs
After receiving the confirmation of technically valid submission through the Gateway or the Web Client from the Agency, the applicants must submit the application to all (Co-)Rapporteurs, otherwise there may be a delay in the start of the procedure due to the time lapse between the validation by the Agency and the confirmation from the (Co-)Rapporteurs that they have received the dossier. In case of a CD-ROM or DVD submission to the EMA, the submission to the (Co-)Rapporteurs should be sent at the same time as the submission is sent to the Agency.
For a full overview of the submission requirements for the different Committee (Co‑)Rapporteurs see:Dossier requirements for Centrally Authorised Products (CAPs).
The above method and requirements also apply to the submission of responses to List of Questions / List of Outstanding Issues.
Validation of the application
In the event that the Agency requires additional data, information or clarification in order to complete its validation of the dossier, it will contact the applicant requesting to supply this information within a specific time limit. When supplying the Agency with this information, the applicant should also send a copy of this information to the (Co-)Rapporteurs. In this case, the validation can only be completed after receipt and verification of the information submitted. The submission of responses to validation additional information (VSI) should be sent in accordance with eCTD requirements as specified in the previous paragraph, including validation additional information (VSI) related to the ASMF part of the dossier, when applicable.
In order to start the procedure by the targeted start date, the Applicant is required to provide the information requested within a given deadline. If the applicant is unable to respond within the deadline, the Agency is able to accept the responses up to 2 months from the VSI letter. The published submission timetable applies. If no response is received within 2 months the validation outcome will be considered negative and the application closed. An invoice for the relevant administrative fee will follow.
If the (Co-)Rapporteurs have not received their copy of the dossier and/or additional validation information on the day where the dossier is validated by the Agency, the start of the procedure may be delayed until the procedural starting date of the next month.
Submission requirements for the other Committee members
After validation of the application, the Agency will notify the applicant accordingly in writing. The same notification will also be sent to the (Co-)Rapporteurs.
Upon receipt of this notification, the MAH should forthwith send the application to the other Committee Members, including any additional data or information supplied during the validation phase as appropriate.
It is essential that identical eCTD sequences are circulated to Committee Members. Any minor changes that affect the 'md5 checksum' will lead to inconsistency and possibly result in future technical invalidity.
For a full overview of the submission requirements for (all Committee members please see:Dossier requirements for Centrally Authorised Products (CAPs).
- "Centralised Procedure", the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2A, Chapter 4
- The Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2B, Electronic Technical Document (eCTD)
- Official Website for ICH
- eSubmission Website
- eSubmission Gateway and the Web Client
- Electronic Application Form
- 28a. What are the names and addresses of the CHMP members? Rev. June 2007
See CHMP members.
- 29. How are initial MAAs validated at the Agency? New July 2013
Initial MAAs submitted to the Agency as part of the centralised procedure are subject to a validation process. The objective is to make sure all essential regulatory elements required for scientific assessment are included in the MAA prior to the start of the procedure. Initial MA validation has been centralised and is now being performed by a dedicated service within the Agency.
There are two elements to validation:
- technical validation, which takes place once an electronic application has been received by the Agency. This ensures that the structure of the submission is compliant with the EU module-1 specification (see eSubmission);
- regulatory and administrative content validation, which can only commence once the application has successfully passed technical validation.
What to expect once an initial MAA has been submitted to the Agency
Once submitted to the Agency in the agreed standard format, the Agency performs a technical validation. The outcome of this technical validation is immediately communicated to the applicant when the application is received via the Gateway portal (the preferred channel). Alternatively, applications received on CD or DVD, or via the eSubmission web client are notified at a later stage only if the submission is technically invalid.
If the dossier is technically invalid and the replacement sequence is not delivered by the intended submission deadline, the start of the procedure is automatically postponed to the next month, as only technically valid and complete applications can be subject to the validation process. This also applies to ASMF submissions.
The Agency will inform the applicant of the start of the regulatory and administrative content validation.
If any issues are found during validation, the Agency will issue a validation-supplementary-information (VSI) request to the applicant. Applicants will have to respond to this request in order to resolve any validation issues before the procedure can start. Any response to this VSI request has to be sent as a new sequence.
The Agency will communicate the outcome of the validation to the applicant. A positive outcome means that the scientific evaluation will start on the next available start date according to the Agency's timetables and the applicant will be invoiced the relevant fee. A negative outcome means that the applicant will have to submit a new application and will be invoiced a negative validation administrative fee.
What are the potential scenarios when validating an initial MAA
There are four potential scenarios:
Scenario one (valid first time, no supplementary information requested)
- The applicant submits a complete application according to the Agency's guidance (see 'what are the main principles that my application should follow in order to pass validation successfully?' below).
- The Agency does not require any additional information.
- The Agency confirms the positive validation to the applicant via a positive validation letter.
- The scientific evaluation starts on the next available start date according to the Agency's timetables.
Scenario two (validation supplementary information requested)
- The applicant submits an application that is not in accordance with the Agency's guidance (see 'what are the main principles that my application should follow in order to pass validation successfully?' below).
- The Agency asks the applicant to submit the additional information, clarifications or corrections via a request for VSI.
- The applicant provides the above additional information within the validation timeline. If the additional information submitted is as requested, the Agency will confirm the positive validation to the applicant.
- The scientific evaluation will start on the next available start date according to the Agency's timetables.
Scenario three (suspension of validation)
- The applicant submits an application that is not in accordance with the Agency's guidance (see 'what are the main principles that my application should follow in order to pass validation successfully?' below).
- The Agency asks the applicant to submit the additional information, clarifications or corrections via a request for VSI.
- If the additional information is not provided as requested and within the validation timeline, the validation will be suspended and the applicant informed accordingly. The applicant will have up to two months from the date of the initial VSI request to provide the additional information, clarifications or corrections.
- Within the two-month period and according to the Agency's timetables, the Agency will confirm the positive validation if all pending issues have been addressed. Otherwise, a negative validation will be generated.
Scenario four (negative validation)
- In the case of non-compliance with applicable legal and regulatory requirements within the abovementioned two months, the Agency will issue a negative validation.
- In that case, the Agency will confirm the negative validation to the applicant via a negative validation letter and invoice the administrative fee.
What are the timelines of an initial MAA?
Validation takes place according to the Agency's procedural timetables. Applications received on or before a quoted submission date will undergo validation by the Agency. The application must receive a positive validation outcome in order for a procedure to start on the next available start date.
What are the main principles that my application should follow in order to pass validation successfully?
The agreed standard format should be used. An eCTD structure according to the TIGes harmonised guidance for eCTD submission should be sent and the format should strictly follow volume 2B of the notice to applicants.
The use of the electronic application form is also highly recommended.
The application form and the different parts and modules of the dossier should be consistent (i.e. the composition must be the same in the application form, in module 3 and in the summary of product characteristics).
How to avoid common validation issues
The following paragraphs provide guidance on how to avoid common issues found during validation that will help to submit an application valid first time.
How to avoid the most common GMP validation issues
Manufacturing authorisations or equivalent for MRA partners (GMP certificates)
- Make sure that the scope covers the activities that a given applicant is seeking registration for in the MAA.
Qualified-person declarations
- Make sure that the qualified-person declaration (annex 5.22) is in accordance with NTA requirements. For human medicinal products, make sure the date of the last audit of the active substance manufacturer(s) is included.
Consistency / missing information
- Make sure that the following sections are consistent:
- sections 2.5.1, 2.5.2 and 220.127.116.11 of the application form versus section 3.2.P.3.1 of module 3;
- section 2.5.3 of the application form versus section 3.2.S.2.1 of module 3;
- a flowchart indicating all manufacturing and control sites involved in the manufacturing process of the medicinal product and the active substance (annex 5.8) versus the application form.
- Make sure that the following documents are not missing:
- documents equivalent to manufacturing authorisation (Article 8.3(k) Dir. 2001/83) for non-EU or -EEA manufacturers. While not explicitly a validation issue, applicants should bear in mind that active-substance manufacturers located in third countries are registered with their local authorities in order to facilitate the import of active substances, in accordance with the Falsified Medicines Directive (Directive 2011/62/EU).
How to avoid the most common good-clinical-practice (GCP) validation issues
- The pivotal studies to support the application in module 2.5 must be identified as such.
- Make sure that a list of inspections conducted or planned by other regulatory authorities related to the product and trial sites involved is provided, preferably attached to the application cover letter. Alternatively provide confirmation that no inspections have taken place or are planned.
- Ensure that the list of investigators (names, addresses and countries), preferably in a tabular form, showing the number of patients enrolled by each site and the total number of sites is included.
- Make sure that a table with the number of patients enrolled per country is included. These should be identified in the clinical study report of each study, for instance in section 10.1 or appendix 16.1.4.
- Make sure that a clear description of the study administrative structure (clear identification of the sponsor and of the parties who have performed the monitoring, data management, statistics, laboratory assessments and randomisation, sites of manufacture, other applicable activities and the location of the trial master file) preferably in a tabular form and indicating the name and address of the site where each activity was performed, responsibilities and scope of each activity is included. These should be identified in the clinical study report of each study, for instance in section 6 or appendix 16.1.4.
How to avoid the most common paediatrics validation issues
- Where applicable, make sure that the full paediatric-investigation-plan (PIP) decision (with all annexes) is submitted and not the opinion. Make sure that the compliance letter is not missing (sometimes applicants only submit only the compliance report).
- In the application form, make sure that the decision number (P/0xxx/YY) is submitted and not the PIP procedure number (EMEA-000xxx-PIPxx-YY). In case of class waivers, make sure that not only the applicability letter is submitted, but also the last class waiver decision (currently CW/1/2011).
How to avoid the most common quality validation issues
- Where permitted, valid justifications for the absence of documents in module 3 must be provided in module 2.3, e.g. for novel excipients or material of human and animal origin.
- Latest versions of certificates of suitability (CEPs) for the active substance (chemical) or transmitting spongiform encephalopathy must be provided.
- make sure that the following sections are consistent with one another:
- section 2.6.1 of the application form versus section 3.2.P.1 of module 3 versus product Information (composition);
- section 2.6.2 of the application form versus module 3.2.A.2 versus module 3.2.R (materials of human or animal origin);
- section 188.8.131.52 of the application form versus module 3.2.P.8.1 versus product information (shelf-life).
- Make sure that the following information is included:
- composition of coating mixtures, printing inks and gelatine capsules (both in application form section 2.6.1 and module 3.2.P.1);
- description of analytical methods and validation – information for all methods should be present in 3.2.S.4 and / or 3.2.P.5.
- ASMFs are often submitted to the Agency in a non-compliant and incomplete format. Applicants should provide the ASMF holder with the requested information in advance of their submission and ensure that the Agency's ASMF submission rules (see quality: active substance) are always followed. Non-compliant or incomplete submissions will result in failed technical validation.
- An ASMF is an integral part of the MAA dossier. If the ASMF procedure is used by the applicant as indicated in section 2.5.3 of the application form, the ASMF should be delivered to the Agency well before the submission deadline, in coordination with the related dossier. If the ASMF is technically invalid or arrives to the Agency after the submission deadline for the given month, the dossier is considered incomplete. In this case, the applicant will be informed of this fact and the validation process will be suspended until a complete dossier is presented. The applicant should liaise with the ASMF holder in order to provide a valid ASMF as soon as possible.
- The validation will be resumed upon receipt of the valid ASMF. Once the validation is finalised, the options are:
- no validation issues. The procedure starts at the next available date;
- validation issues identified. A VSI letter will be issued and deadline for responses identified. The following steps are as above (scenarios 2, 3 or 4).
- Check there are no missing expert statements in the ASMF
- ASMF holders are encouraged to use the eSubmission tool, i.e. the Gateway or web-client portal. This prevents delays related to courier services, holidays and technical validation.
Other frequently encountered issues
- Application for the new active substance status should be presented as annex 5.23 to the application form (required as of 3 June 2013).
- Name of the active substance in the application form:
- title page, section 2.2.1, section 2.6.1: active substance including salt or hydrate;
- section 2.1.2: international non-proprietary name.
- Strength of the dosage form in the dossier and product information should be expressed per active moiety (i.e. base), corresponding to the actual salt, e.g. exemplain 120 mg (corresponding to 135 mg exemplain hydrochloride). Also see Quality Review of Documents recommendations on the expression of strength in the name of centrally authorised human medicinal products.
- Section 2.6.2 of the application form and modules 3.2.A.2 and 3.2.R should contain all materials of human and animal origin, including those used during manufacture of the active substance (e.g. components of fermentation media), while module 3.2.P.4.5 only relates to excipients.
- Where applicable, justification for not using a standard term for pharmaceutical form should be placed in module 1.3.
- Excipients should be tested according to a European Pharmacopoiea (Ph. Eur.) monograph where available. Where no Ph. Eur. monograph exists, other pharmacopoeias may be used as supportive but description and validation of the methods used should be provided. For detailed requirements, see the guideline on excipients in the dossier for application for marketing authorisation of a medicinal product.
- Ph. Eur. analytical methods should be used whenever possible (e.g. for heavy metals, loss on drying).
How to avoid the most common non-clinical and clinical validation issues
- When documents in modules 4 or 5 are absent, a valid justification must be provided:
- The non-clinical overview and summaries should be structured following the indents of module 4.
- The clinical overview and summaries do not mandate explicitly addressing some indents of module 5 (most commonly: 184.108.40.206 comparative bioavailability and bioequivalence (BE); 22.214.171.124 in-vitro-in-vivo correlation; 220.127.116.11 study reports of controlled clinical studies; 188.8.131.52 study reports of uncontrolled clinical studies). Justifications for the absence of studies in any indent of module 5, even when it is considered self-explanatory, should be included in the clinical overview.
- Make sure that a valid justification for empty eCTD modules and indents is provided, i.e. a statement that relevant studies have not been conducted or are not available is not considered a valid justification. Even if it is straightforward or a matter of development strategy (e.g. reliance of outstanding results from uncontrolled studies to support marketing authorisation application in the absence of controlled data), the reason for ultimately not submitting certain studies should be explained.
- Make sure that justifications are easy to locate and identify. Validation does not entail extensive review of submitted materials, but only identification of legally required elements. Providing a necessary justification for empty eCTD modules or indents within a discussion may prevent the validation officer from identifying it. One may want to place such justifications under relevant subsections of the (non-)clinical overview or provide them as an annex at the end of the (non-)clinical overview, making sure of the use of the correct terminology of the indent.
How to avoid the most common pharmacovigilance validation issues
- Make sure that a statement indicating that the applicant has the necessary means to fulfil the tasks and responsibilities listed in title IX of Directive 2001/83/EC is included.
- Make sure there is a reference to the location where the pharmacovigilance-system master file for the medicinal product is kept.
- 30. When should I submit my MAA? Rev. March 2013
In the same way as it is important for applicants to plan their application strategies for an efficient use of their resources, it is important for the Agency, committee members and experts to be able to plan and allocate their workload efficiently. If the actual submission date is several months after the date originally indicated, the (co-)rapporteur may find it difficult to provide the necessary expertise and re-appointment could be necessary.
The Agency advises applicants to consider the date of submission very carefully and to notify the Agency and (co-)rapporteur of a 'real' submission date.
At least seven months before submission, applicants should notify the Agency of their intention to submit an MAA and provide the intended date of submission. This should be done by using the presubmission request form, selecting 'centralised procedure - intent to submit an MAA' as the scope of the request. This should be sent to firstname.lastname@example.com. The appointment procedure for (co-)rapporteurs will be initiated seven months prior to the MAA intended submission date (see 'what is the procedure for appointment of CHMP rapporteurs, co-rapporteurs and their assessment teams?' on presubmission guidance: questions 1-10).
Furthermore, applicants are requested to notify the Agency and (co-)rapporteurs as soon as possible when the previously notified submission date cannot be met, by re-sending an updated presubmission request form, selecting 'notification of change - applicant /contact person details' as the scope of the request.
Applicants are finally requested, if they no longer wish to pursue the submission of their application, to notify the Agency of their intention to withdraw the request for submission of the MAA. This should be done by using the presubmission request form, selecting 'withdrawal of request' as the scope of the request. This should be sent electronically to firstname.lastname@example.com. This will close the case procedure and the whole presubmission history.
The submission deadlines and full procedural detailed timetables are published as a generic calendar on submission dates. The published timetables identify the submission, start and finish dates of the procedures as well as other interim dates and milestones that occur during the procedure. Applicants should ensure that a technically valid eCTD submission is received by the Agency before the submission deadline. Any technically invalid sequences will result in non-acceptance, which may cause a delay in the start of the procedure.
In order to accelerate and facilitate the procedure, applicants must submit, in parallel to the Agency, the required copies of the dossier to both the all (co-)rapporteurs, as stated in dossier requirements for centrally authorised products. Please note that the Agency requires only one eSubmission Gateway or web-client submission without any paper cover letter. Alternatively, one CD or DVD and one signed paper cover letter can be sent.
Soon after the notification of a valid application, the Agency will send an invoice to the applicant. The fees should be paid within 30 days of the receipt of this invoice. For more information regarding the applicable fee, see 'what fee do I have to pay and how is the appropriate fee for my application calculated?' on presubmission guidance: questions 1-10.
For more information on the complete set of documents that need to be submitted and for the addresses of CHMP members for submission of the application, see 'how and to whom shall I submit my dossier and how many copies?'


text:
Do you spend your day at a desk or in front of a computer? I
get asked all the time "How should I be sitting at my desk?" Even
though some of you have access to ergonomic evaluations for your workstation,
many people are still sitting with incorrect posture.
Here are a few tips to make your work station a bit safer:
1. When you sit in your ergonomic chair, your feet should touch the ground or
rest on something solid. Phone books work as good stools.
2. The chair itself should be fully adjustable from the arm rests, the seat
height, the back rest and the tilt angle of the seat. Most expensive chairs
have all these features, but not all chairs will. Do your best in trying to
adjust these areas.
3. The top of the monitor should be at the level of your eyes. This way, when
you are looking down, the full monitor is in your view. This allows your head
to stay in a neutral position, not looking too far down or up.
4. Put your arms comfortably at your sides. When you bend your elbows and have your arms/forearms at 90 degrees or perfectly horizontal, that is the level
your desk should be at. That is also the level where your mouse should be, as
5. Do not perch on the edge of the chair! Make sure you sit all the way to the
back of the seat so that your back feels the back rest. Perching on the edge
really stresses out the lower and mid back.
There is a lot of information in these five suggestions so make sure you read them over and implement them at your desk at home and at work.
If there's something you've read and need clarification on, then go ahead and give the office a call at 631-647-8324 or e-mail us at email@example.com.
Have a GREAT day!
~Dr. Laura Bowen
Islip Chiropractic PC


text:
Bankers' Quest to Build Bikes of Joy for Phuket Orphanage
Media Release
Big-hearted Singapore bankers got on their bikes to bring joy to youngsters of a Phuket orphanage in a unique training programme devised and staged by Quest, the corporate team building organisation.
More than 210 senior management and staff of the Singapore bank took time out from their recent conference at Angsana Laguna Phuket to spend a morning at Baan Sosa Orphanage taking part in the Quest programme – dubbed the "Great Bike Build."
They were split into teams to work on problem-solving tasks and issued with bike parts, which were later assembled into mountain bikes with the help of a professional bike technician.
Twenty completed bikes were then handed over to the youngsters – and in a heart-warming gesture the bankers also made a donation of THB 125,000 (S$ 4,947) to the orphanage.
"This was probably the most powerful programme we have ever operated," said Alun Gathergood, Quest regional manager. "It was an emotional experience for everyone concerned - and some tears were shed at the handover."
Baan Sosa Orphanage is home to 120 orphaned children aged from four to 16 years-old and is one of five orphanages in Thailand administered by the Australian-based SOS Foundation and supported by Thai Royal Family patronage.
Phuket-based Quest, Asia's leading and most innovative corporate team building organisation, also offers programmes on the Indonesian resort island of Bintan near Singapore and is poised for further expansion throughout the region.
Quest will be managing team-building operations at the new Laguna Lang Co resort in central Vietnam, due to open later in 2012. Its head office is at Laguna Phuket, where it has been operating since 1995. More information at: www.questleadingtheway.com
Laguna Holiday Club is part of the Laguna Phuket Destination Resort.
Learn more about Laguna Phuket